ELSPAR Side Effects

5573595-2 | Dysplastic Naevus Syndrome, Malignant Melanoma
on Dec 05, 2007 Male patient from UNITED STATES , 17 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: dysplastic naevus syndrome, malignant melanoma. Elspar dosage: . During the same period patient was treated with PREDNISONE (View Prednisone Review and Prednisone Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), MERCAPTOPURINE (View Mercaptopurine Review and Mercaptopurine Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), DAUNORUBICIN HCL (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ).

5573076-6 | Blood Cholesterol Increased, Blood Triglycerides Increased, Hyperlipidaemia
Patient was taking Elspar (View Usage). Patient had the following side effects: blood cholesterol increased, blood triglycerides increased, hyperlipidaemia on Dec 07, 2007 from UNITED KINGDOM Additional patient health information: Male patient , child 5 years of age, weighting 44.09 lb, was diagnosed with acute lymphocytic leukaemia and. Elspar dosage: . During the same period patient was treated with VINCRISTINE (View Vincristine Review and Vincristine Label ), DEXAMETHASONE TAB (View Dexamethasone Tab Review and Dexamethasone Tab Label ).

5572416-1 | Blood Creatinine Increased, Blood Urea Increased, Hyperglycaemic Hyperosmolar Nonketotic Syndrome
Adverse event was reported on Dec 04, 2007 by a Female patient taking Elspar (View Usage) (Dosage: ; Qd;) was diagnosed with acute lymphocytic leukaemia and. Location: TURKEY , child 10 years of age, After Elspar was administered, patient had the following side effects: blood creatinine increased, blood urea increased, hyperglycaemic hyperosmolar nonketotic syndrome. During the same period patient was treated with PREDNISONE (30 Mg/kg; Qd;) (View Prednisone Review and Prednisone Label ).

5523216-X | Abasia, Atrial Fibrillation, Bacterial Infection, Blood Culture Positive, Diarrhoea, Hypokalaemia, Hypotension, Lethargy, Neutropenia
on Nov 16, 2007 Female patient from UNITED STATES , weighting 244.7 lb, was treated with Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: abasia, atrial fibrillation (What is atrial fibrillation?), bacterial infection (What is bacterial infection?), blood culture positive, diarrhoea, hypokalaemia, hypotension, lethargy, neutropenia. Elspar dosage: 38042 Unit. During the same period patient was treated with VINCRISTINE SULFATE (2 Mg) (View Vincristine Sulfate Review and Vincristine Sulfate Label ), BACTRIM DS (9) (View Bactrim Ds Review and Bactrim Ds Label ), CYCLOPHOSPHAMIDE (2508 Mg) (View Cyclophosphamide Review and Cyclophosphamide Label ), DAUNORUBICIN HCL (501 Mg) (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ), DEXAMETHASONE TAB (12 Mg) (View Dexamethasone Tab Review and Dexamethasone Tab Label ), G CSF (FILGRASTIM, AMGEN) (5280 Mg) (View G-csf (filgrastim, Amgen) Review and G-csf (filgrastim, Amgen) Label ). Patient was hospitalized.


5430015-6 | Convulsion, Ischaemic Stroke, Pancreatic Cyst, Pancreatic Pseudocyst, Pancreatitis
on Aug 13, 2007 Female patient from POLAND , child 7 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient had the following side effects: convulsion, ischaemic stroke, pancreatic cyst, pancreatic pseudocyst, pancreatitis. Elspar dosage: Iv. Patient was hospitalized.

5417517-3 | Phlebitis, Pyrexia
Patient was taking Elspar (View Usage). After Elspar was administered, patient had the following side effects: phlebitis, pyrexia on Jun 15, 2007 from SPAIN Additional patient health information: Female patient , child 11 years of age, weighting 110.2 lb, was diagnosed with granulocytopenia and. Elspar dosage: . During the same period patient was treated with CANCIDAS (View Cancidas Review and Cancidas Label ), AMPHOTERICIN B (View Amphotericin B Review and Amphotericin B Label ). Patient was hospitalized.

5416510-4 | Cardiovascular Insufficiency, Hepatomegaly, Liver Disorder, Pancreatic Pseudocyst, Respiratory Failure, Transaminases Increased
Adverse event was reported on Aug 01, 2007 by a Female patient taking Elspar (View Usage) (Dosage: ; Iv) was diagnosed with acute lymphocytic leukaemia and. Location: POLAND , child 5 years of age, Patient experienced the following unwanted or unexpected effects: cardiovascular insufficiency, hepatomegaly, liver disorder, pancreatic pseudocyst, respiratory failure, transaminases increased. Patient was hospitalized.

5416507-4 | Convulsion, Cyst, Ischaemic Stroke, Pancreatic Pseudocyst, Pancreatitis, Treatment Failure
on Aug 01, 2007 Female patient from POLAND , child 7 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient had the following side effects: convulsion, cyst, ischaemic stroke, pancreatic pseudocyst, pancreatitis, treatment failure. Elspar dosage: ;iv. Patient was hospitalized.

5409627-1 | Chills, Fatigue, Hepatic Function Abnormal, Lung Consolidation, Lung Neoplasm, Neutropenia, Opportunistic Infection, Pulmonary Mass
on Jul 24, 2007 Female patient from UNITED STATES , 57 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). After Elspar was administered, patient had the following side effects: chills, fatigue, hepatic function abnormal, lung consolidation, lung neoplasm, neutropenia, opportunistic infection, pulmonary mass. Elspar dosage: . During the same period patient was treated with DAUNORUBICIN HCL (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ), IMATINIB MESYLATE (View Imatinib Mesylate Review and Imatinib Mesylate Label ). Patient was hospitalized.

5390861-4 | Pancreatic Pseudocyst, Pancreatitis Acute
Patient was taking Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: pancreatic pseudocyst, pancreatitis acute on Jul 06, 2007 from JAPAN Additional patient health information: Male patient , child 11 years of age, was diagnosed with acute lymphocytic leukaemia and. Elspar dosage: Im.

5378358-9 | Acute Hepatic Failure, Dehydration, Electrolyte Imbalance, Hepatic Encephalopathy, Mental Status Changes, Weight Decreased
Adverse event was reported on Jul 02, 2007 by a Male patient taking Elspar (View Usage) (Dosage: 90120 Mg) . Location: UNITED STATES , weighting 192.5 lb, Patient had the following side effects: acute hepatic failure, dehydration, electrolyte imbalance, hepatic encephalopathy, mental status changes, weight decreased. Patient was hospitalized.

5372797-8 | Pancreatic Pseudocyst, Pancreatitis Acute
on Jun 18, 2007 Male patient from JAPAN , child 11 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). After Elspar was administered, patient had the following side effects: pancreatic pseudocyst, pancreatitis acute. Elspar dosage: .

5372795-4 | Convulsion, Hyperammonaemia, Hypertriglyceridaemia, Superior Sagittal Sinus Thrombosis, Transverse Sinus Thrombosis
on Jun 17, 2007 Male patient from GERMANY , 15 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: convulsion, hyperammonaemia, hypertriglyceridaemia, superior sagittal sinus thrombosis, transverse sinus thrombosis. Elspar dosage: . During the same period patient was treated with DEXAMETHASONE TAB (View Dexamethasone Tab Review and Dexamethasone Tab Label ). Patient was hospitalized.

5372102-7 | Phlebitis, Pyrexia
Patient was taking Elspar (View Usage). Patient had the following side effects: phlebitis, pyrexia on Jun 15, 2007 from SPAIN Additional patient health information: Female patient , child 11 years of age, weighting 110.2 lb, was diagnosed with granulocytopenia and. Elspar dosage: . During the same period patient was treated with CANCIDAS (View Cancidas Review and Cancidas Label ), AMPHOTERICIN B (View Amphotericin B Review and Amphotericin B Label ). Patient was hospitalized.

5341181-5 | Fungal Sepsis, Hepatic Steatosis, Neutropenia, Pancreatitis, Perirenal Haematoma, Pneumonia, Respiratory Failure, Retroperitoneal Haemorrhage
Adverse event was reported on May 15, 2007 by a Male patient taking Elspar (View Usage) (Dosage: 6000 Iu;tiw, 9 Doses) was diagnosed with t-cell lymphoma and. Location: UNITED STATES , child 5 years of age, After Elspar was administered, patient had the following side effects: fungal sepsis, hepatic steatosis, neutropenia, pancreatitis, perirenal haematoma, pneumonia (What is pneumonia?), respiratory failure, retroperitoneal haemorrhage. During the same period patient was treated with PREDNISONE TAB (60 Mg/m**2;1x;) (View Prednisone Tab Review and Prednisone Tab Label ), VINCRISTINE (1.5 Mg/m**2;qw X 4 Doses) (View Vincristine Review and Vincristine Label ), DAUNORUBICIN HCL (25 Mg/m**2;qw X 4 Doses) (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ).

5328392-X | Altered State Of Consciousness, Blood Bilirubin Increased, Brain Oedema, Cerebral Haemorrhage, Convulsion, Hemiplegia, Superior Sagittal Sinus Thrombosis
on May 01, 2007 Male patient from JAPAN , 25 years of age, weighting 150.6 lb, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: altered state of consciousness, blood bilirubin increased, brain oedema, cerebral haemorrhage, convulsion, hemiplegia, superior sagittal sinus thrombosis. Elspar dosage: . During the same period patient was treated with ADRIAMYCIN PFS (10 Mg/m**2) (View Adriamycin Pfs Review and Adriamycin Pfs Label ), VINCRISTINE (1.4 Mg/m**2;) (View Vincristine Review and Vincristine Label ), CYCLOPHOSPHAMIDE (650 Mg/m**2;) (View Cyclophosphamide Review and Cyclophosphamide Label ), MITOXANTRONE (6 Mg/m**2) (View Mitoxantrone Review and Mitoxantrone Label ), PREDNISOLONE (40 Mg/m**2;) (View Prednisolone Review and Prednisolone Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ). Patient was hospitalized.

5308999-6 | Convulsion, Superior Sagittal Sinus Thrombosis
on Apr 10, 2007 Male patient from JAPAN , 25 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient had the following side effects: convulsion, superior sagittal sinus thrombosis. Elspar dosage: . During the same period patient was treated with CYTARABINE (View Cytarabine Review and Cytarabine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

5267343-3 | Bacterial Infection, Disease Progression, Fungal Infection, Haemoptysis, Mucosal Inflammation, Musculoskeletal Disorder, Pyelonephritis Fungal, Renal Disorder, Respiratory Disorder
Patient was taking Elspar (View Usage). After Elspar was administered, patient had the following side effects: bacterial infection (What is bacterial infection?), disease progression, fungal infection (What is fungal infection?), haemoptysis, mucosal inflammation, musculoskeletal disorder, pyelonephritis fungal, renal disorder, respiratory disorder on Feb 27, 2007 from UNITED STATES Additional patient health information: Male patient , 21 years of age, was diagnosed with acute lymphocytic leukaemia and. Elspar dosage: . During the same period patient was treated with VINCRISTINE (View Vincristine Review and Vincristine Label ), DEXAMETHASONE (View Dexamethasone Review and Dexamethasone Label ).

5218370-3 | Erythema, Hyperhidrosis, Infusion Related Reaction
Adverse event was reported on Jan 23, 2007 by a Male patient taking Elspar (View Usage) (Dosage: 12500 Units Daily Iv) was diagnosed with t-cell lymphoma and. Location: UNITED STATES , weighting 184.0 lb, Patient experienced the following unwanted or unexpected effects: erythema, hyperhidrosis, infusion related reaction. During the same period patient was treated with ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), CENTRUM (View Centrum Review and Centrum Label ), DEXAMETHASONE (View Dexamethasone Review and Dexamethasone Label ), DIPHENHYDRAMINE HCL (View Diphenhydramine Hcl Review and Diphenhydramine Hcl Label ), DOCUSATE (View Docusate Review and Docusate Label ), FLUCONAZOLE (View Fluconazole Review and Fluconazole Label ), FLUTICASONE PROPIONATE (View Fluticasone Propionate Review and Fluticasone Propionate Label ), GRANISETRON (View Granisetron Review and Granisetron Label ).

5192743-X | Ischaemic Stroke
on Dec 05, 2006 Male patient from BRAZIL , 17 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient had the following side effects: ischaemic stroke. Elspar dosage: 5000 Iu/m**2; Three Administrations;. During the same period patient was treated with ANTHRACYCLINES (View Anthracyclines Review and Anthracyclines Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ).

5192719-2 | Ischaemic Cerebral Infarction
on Dec 05, 2006 Male patient from BRAZIL , 22 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). After Elspar was administered, patient had the following side effects: ischaemic cerebral infarction. Elspar dosage: 5000 Iu/m**2; /nine Administrations;. During the same period patient was treated with ANTHRACYCLINES (View Anthracyclines Review and Anthracyclines Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ).

5192716-7 | Cerebrovascular Accident
Patient was taking Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: cerebrovascular accident on Dec 05, 2006 from BRAZIL Additional patient health information: Female patient , 46 years of age, was diagnosed with acute lymphocytic leukaemia and. Elspar dosage: 10000 Iu/m**2; Every Other 2 Or 3 Days; Iv. During the same period patient was treated with ANTHRACYCLINES (View Anthracyclines Review and Anthracyclines Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ). Patient was hospitalized.

5172666-2 | Cerebrovascular Accident
Adverse event was reported on Nov 20, 2006 by a Female patient taking Elspar (View Usage) (Dosage: 10000 Iu/m**2; Every Other 2 Or 3 Days; Iv) was diagnosed with acute lymphocytic leukaemia and. Location: BRAZIL , 46 years of age, Patient had the following side effects: cerebrovascular accident. During the same period patient was treated with ANTHRACYCLINES (View Anthracyclines Review and Anthracyclines Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ). Patient was hospitalized.

5172665-0 | Cerebral Ischaemia
on Nov 22, 2006 Male patient from BRAZIL , 17 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). After Elspar was administered, patient had the following side effects: cerebral ischaemia. Elspar dosage: 5000 Iu/m**2; Three Administrations;. During the same period patient was treated with ANTHRACYCLINES (View Anthracyclines Review and Anthracyclines Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ).

5172664-9 | Intracranial Venous Sinus Thrombosis
on Nov 22, 2006 Female patient from BRAZIL , 17 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: intracranial venous sinus thrombosis. Elspar dosage: 10000 Iu/m**2; Q3d;. During the same period patient was treated with ANTHRACYCLINES (View Anthracyclines Review and Anthracyclines Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ).

5172663-7 | Cerebral Ischaemia
Patient was taking Elspar (View Usage). Patient had the following side effects: cerebral ischaemia on Nov 22, 2006 from BRAZIL Additional patient health information: Male patient , 22 years of age, was diagnosed with acute lymphocytic leukaemia and. Elspar dosage: 5000 Iu/m**2; /nine Administrations;. During the same period patient was treated with ANTHRACYCLINES (View Anthracyclines Review and Anthracyclines Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ).

5114563-4 | Cerebral Haematoma, Coagulopathy, Constipation, Hemiparesis, Myelopathy, Neutropenia, Paraplegia, Urinary Incontinence
Adverse event was reported on Sep 08, 2006 by a Male patient taking Elspar (View Usage) (Dosage: Iv) was diagnosed with acute lymphocytic leukaemia and. Location: SPAIN , 16 years of age, After Elspar was administered, patient had the following side effects: cerebral haematoma, coagulopathy, constipation (What is constipation?), hemiparesis, myelopathy, neutropenia, paraplegia, urinary incontinence (What is urinary incontinence?). During the same period patient was treated with DAUNORUBICIN HCL (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ), MERCAPTOPURINE (View Mercaptopurine Review and Mercaptopurine Label ).

5097771-0 | Cerebral Haematoma, Coagulopathy, Constipation, Myelopathy, Urinary Incontinence
on Aug 18, 2006 Male patient from SPAIN , 16 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: cerebral haematoma, coagulopathy, constipation (What is constipation?), myelopathy, urinary incontinence (What is urinary incontinence?). Elspar dosage: Iv. During the same period patient was treated with DAUNORUBICIN HCL (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ), MERCAPTOPURINE (View Mercaptopurine Review and Mercaptopurine Label ).

5089458-5 | Blood Thrombin Decreased, Convulsion, Depressed Level Of Consciousness, Gait Disturbance, Haemorrhagic Cerebral Infarction, Hemiplegia, Hypocoagulable State, Leukaemia Recurrent
on Aug 09, 2006 Male patient from JAPAN , 14 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient had the following side effects: blood thrombin decreased, convulsion, depressed level of consciousness, gait disturbance, haemorrhagic cerebral infarction, hemiplegia, hypocoagulable state, leukaemia recurrent. Elspar dosage: .

5089455-X | Coagulation Test Abnormal, Haemorrhagic Cerebral Infarction, Hypocoagulable State, Intracranial Venous Sinus Thrombosis
Patient was taking Elspar (View Usage). After Elspar was administered, patient had the following side effects: coagulation test abnormal, haemorrhagic cerebral infarction, hypocoagulable state, intracranial venous sinus thrombosis on Aug 09, 2006 from JAPAN Additional patient health information: Male patient , child 9 years of age, was diagnosed with acute lymphocytic leukaemia and. Elspar dosage: .

5072931-3 | Epistaxis, Febrile Neutropenia, Fungal Infection, Mucous Membrane Disorder, Nasal Septum Perforation, Pulmonary Mycosis, Sinus Disorder
Adverse event was reported on Jul 14, 2006 by a Female patient taking Elspar (View Usage) (Dosage: ) was diagnosed with acute lymphocytic leukaemia and. Location: ISRAEL , child 8 years of age, Patient experienced the following unwanted or unexpected effects: epistaxis, febrile neutropenia, fungal infection (What is fungal infection?), mucous membrane disorder, nasal septum perforation, pulmonary mycosis, sinus disorder. During the same period patient was treated with PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), DAUNORUBICIN HCL (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ), METHOTREXATE (Inth) (View Methotrexate Review and Methotrexate Label ), TRIMETHOPRIM SULPHAMETHOXAZOLE (View Trimethoprim-sulphamethoxazole Review and Trimethoprim-sulphamethoxazole Label ).

5069908-0 | Epistaxis, Febrile Neutropenia, Fungal Infection, Mucous Membrane Disorder, Nasal Septum Perforation, Pulmonary Mycosis
on Jul 14, 2006 Female patient from ISRAEL , child 8 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient had the following side effects: epistaxis, febrile neutropenia, fungal infection (What is fungal infection?), mucous membrane disorder, nasal septum perforation, pulmonary mycosis. Elspar dosage: . During the same period patient was treated with PREDNISONE TAB (View Prednisone Tab Review and Prednisone Tab Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), DAUNORUBICIN HCL (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ), METHOTREXATE (Inth) (View Methotrexate Review and Methotrexate Label ), TRIMETHOPRIM SULPHAMETHOXAZOLE (View Trimethoprim-sulphamethoxazole Review and Trimethoprim-sulphamethoxazole Label ).

5067195-0 | Disease Progression, Primitive Neuroectodermal Tumour
on Jul 12, 2006 Male patient from TURKEY , child 10 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). After Elspar was administered, patient had the following side effects: disease progression, primitive neuroectodermal tumour. Elspar dosage: . During the same period patient was treated with DACTINOMYCIN (View Dactinomycin Review and Dactinomycin Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), ADRIAMYCIN PFS (View Adriamycin Pfs Review and Adriamycin Pfs Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), ETOPOSIDE (View Etoposide Review and Etoposide Label ), MERCAPTOPURINE (View Mercaptopurine Review and Mercaptopurine Label ).

5067192-5 | Metastasis, Mucoepidermoid Carcinoma
Patient was taking Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: metastasis, mucoepidermoid carcinoma on Jul 12, 2006 from TURKEY Additional patient health information: Female patient , 13 years of age, was diagnosed with acute lymphocytic leukaemia and. Elspar dosage: . During the same period patient was treated with DACTINOMYCIN (View Dactinomycin Review and Dactinomycin Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), ADRIAMYCIN PFS (View Adriamycin Pfs Review and Adriamycin Pfs Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), ETOPOSIDE (View Etoposide Review and Etoposide Label ), MERCAPTOPURINE (View Mercaptopurine Review and Mercaptopurine Label ).

5067189-5 | Ewing's Sarcoma, Metastasis
Adverse event was reported on Jul 12, 2006 by a Male patient taking Elspar (View Usage) (Dosage: ) was diagnosed with acute lymphocytic leukaemia and. Location: TURKEY , child 3 years of age, Patient had the following side effects: ewing's sarcoma, metastasis. During the same period patient was treated with VINCRISTINE (View Vincristine Review and Vincristine Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), ETOPOSIDE (View Etoposide Review and Etoposide Label ), MERCAPTOPURINE (View Mercaptopurine Review and Mercaptopurine Label ).

5017558-4 | Abdominal Infection, Abdominal Pain, Blood Culture Positive, Nausea, Pancreatitis Necrotising
on Jun 01, 2006 Female patient from UNITED STATES , 24 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). After Elspar was administered, patient had the following side effects: abdominal infection, abdominal pain (What is abdominal pain?), blood culture positive, nausea (What is nausea?), pancreatitis necrotising. Elspar dosage: 11,000 Units/m2 2x/week Sq. Patient was hospitalized.

4993662-1 | Contusion, Petechiae, Thrombocytopenic Purpura
on Apr 27, 2006 Male patient from CANADA , 16 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: contusion, petechiae, thrombocytopenic purpura. Elspar dosage: . During the same period patient was treated with DECADRON (View Decadron Review and Decadron Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), DAUNORUBICIN (View Daunorubicin Review and Daunorubicin Label ), DOXORUBICIN (View Doxorubicin Review and Doxorubicin Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), MERCAPTOPURINE (View Mercaptopurine Review and Mercaptopurine Label ), THIOGUANINE (View Thioguanine Review and Thioguanine Label ). Patient was hospitalized.

4993658-X | Thrombocytopenic Purpura
Patient was taking Elspar (View Usage). Patient had the following side effects: thrombocytopenic purpura on Apr 27, 2006 from CANADA Additional patient health information: Female patient , child 10 years of age, was diagnosed with acute lymphocytic leukaemia, prophylaxis and. Elspar dosage: . During the same period patient was treated with DECADRAN (DEXAMETHASONE) (View Decadran (dexamethasone) Review and Decadran (dexamethasone) Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), DAUNORUBICIN (View Daunorubicin Review and Daunorubicin Label ), DOXORUBICIN (View Doxorubicin Review and Doxorubicin Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), MERCAPTOPURINE (View Mercaptopurine Review and Mercaptopurine Label ).

4993639-6 | Contusion, Petechiae, Thrombocytopenic Purpura
Adverse event was reported on Apr 27, 2006 by a Female patient taking Elspar (View Usage) (Dosage: ) was diagnosed with acute lymphocytic leukaemia, prophylaxis and. Location: CANADA , child 6 years of age, After Elspar was administered, patient had the following side effects: contusion, petechiae, thrombocytopenic purpura. During the same period patient was treated with DECADRON (View Decadron Review and Decadron Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), DAUNORUBICIN (View Daunorubicin Review and Daunorubicin Label ), DOXORUBICIN (View Doxorubicin Review and Doxorubicin Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), CYTARABINE (View Cytarabine Review and Cytarabine Label ), MERCAPTOPURINE (View Mercaptopurine Review and Mercaptopurine Label ).

4978723-5 | Asthenia, Injection Site Rash, Serum Sickness
on Apr 12, 2006 Female patient from UNITED STATES , 50 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: asthenia, injection site rash, serum sickness. Elspar dosage: . During the same period patient was treated with VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ). Patient was hospitalized.

4966314-1 | Aortic Embolus, Deep Vein Thrombosis, Embolism, Intracardiac Thrombus, Pulmonary Embolism, Splenic Infarction
on Mar 31, 2006 Male patient from UNITED STATES , 20 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient had the following side effects: aortic embolus, deep vein thrombosis (What is deep vein thrombosis?), embolism, intracardiac thrombus, pulmonary embolism (What is pulmonary embolism?), splenic infarction. Elspar dosage: . During the same period patient was treated with DAUNORUBICIN (View Daunorubicin Review and Daunorubicin Label ), VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ), PREDNISONE (View Prednisone Review and Prednisone Label ).

4955893-6 | Asthenia, Catheter Site Related Reaction, Electrolyte Imbalance, Neck Pain, Odynophagia, Pharyngolaryngeal Pain, Staphylococcal Infection, Thrombosis
Patient was taking Elspar (View Usage). After Elspar was administered, patient had the following side effects: asthenia, catheter site related reaction, electrolyte imbalance, neck pain, odynophagia, pharyngolaryngeal pain, staphylococcal infection (What is staphylococcal infection?), thrombosis on Mar 27, 2006 from UNITED STATES Additional patient health information: Male patient , weighting 160.9 lb, was diagnosed with acute lymphocytic leukaemia and. Elspar dosage: 69000 Unit. During the same period patient was treated with G CSF (FILGRASTIM, AMEGEN) (4050 Mg) (View G-csf (filgrastim, Amegen) Review and G-csf (filgrastim, Amegen) Label ), DAUNORUBICIN HCL (450 Mg) (View Daunorubicin Hcl Review and Daunorubicin Hcl Label ), CYCLOPHOSPHAMIDE (2300 Mg) (View Cyclophosphamide Review and Cyclophosphamide Label ), ALLOPURINOL (3000 Mg) (View Allopurinol Review and Allopurinol Label ). Patient was hospitalized.

4954360-3 | Cerebral Infarction, Simple Partial Seizures
Adverse event was reported on Mar 16, 2006 by a Female patient taking Elspar (View Usage) (Dosage: ) was diagnosed with acute lymphocytic leukaemia and. Location: PHILIPPINES , child 8 years of age, Patient experienced the following unwanted or unexpected effects: cerebral infarction, simple partial seizures. During the same period patient was treated with VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ).

4954242-7 | Cerebral Infarction, Coma, Grand Mal Convulsion
on Mar 16, 2006 Female patient from PHILIPPINES , child 7 years of age, was diagnosed with acute lymphocytic leukaemia recurrent and was treated with Elspar (View Usage). Patient had the following side effects: cerebral infarction, coma, grand mal convulsion. Elspar dosage: . During the same period patient was treated with VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ), EPIRUBICIN HYDROCHLORIDE (View Epirubicin Hydrochloride Review and Epirubicin Hydrochloride Label ). Patient was hospitalized.

4944862-8 | Pancreatitis Acute
on Jan 14, 2005 Male patient from UNITED STATES , child 4 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). After Elspar was administered, patient had the following side effects: pancreatitis acute. Elspar dosage: 10000 Iu Iv. During the same period patient was treated with MERCAPTOPURINE (View Mercaptopurine Review and Mercaptopurine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ). Patient was hospitalized.

4873524-0 | Abdominal Pain, Convulsion, Hyponatraemia, Nephrolithiasis, Neurological Symptom, Neutropenia, Oral Intake Reduced, Pyrexia, Respiratory Depression
Patient was taking Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal pain (What is abdominal pain?), convulsion, hyponatraemia, nephrolithiasis, neurological symptom, neutropenia, oral intake reduced, pyrexia, respiratory depression on Dec 30, 2005 from AUSTRALIA Additional patient health information: Male patient , child 6 years of age, was diagnosed with acute lymphocytic leukaemia, mediastinal mass and. Elspar dosage: . During the same period patient was treated with VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ), DAUNORUBICIN (View Daunorubicin Review and Daunorubicin Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ).

4864748-7 | Haemoptysis, Lung Abscess, Sepsis Syndrome
Adverse event was reported on Dec 19, 2005 by a Male patient taking Elspar (View Usage) (Dosage: ) was diagnosed with natural killer-cell leukaemia and. Location: JAPAN , 68 years of age, Patient had the following side effects: haemoptysis, lung abscess, sepsis syndrome. During the same period patient was treated with DOXORUBICIN (View Doxorubicin Review and Doxorubicin Label ), VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ). Patient was hospitalized.

4836047-0 | Convulsion, Feeling Abnormal, Hypersensitivity, Pruritus, Vomiting
on Nov 17, 2005 Female patient from UNITED STATES , 37 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). After Elspar was administered, patient had the following side effects: convulsion, feeling abnormal, hypersensitivity, pruritus, vomiting. Elspar dosage: . Patient was hospitalized.

4826516-1 | Activated Partial Thromboplastin Time Prolonged, Antithrombin Iii Decreased, Blood Fibrinogen Decreased, Cerebral Infarction, Clonic Convulsion, Coagulation Factor Ix Level Decreased, Depressed Level Of Consciousness, Eyelid Oedema, Face Oedema
on Jan 14, 2005 Female patient from JAPAN , 48 years of age, weighting 116.8 lb, was diagnosed with acute lymphocytic leukaemia and was treated with Elspar (View Usage). Patient experienced the following unwanted or unexpected effects: activated partial thromboplastin time prolonged, antithrombin iii decreased, blood fibrinogen decreased, cerebral infarction, clonic convulsion, coagulation factor ix level decreased, depressed level of consciousness, eyelid oedema, face oedema. Elspar dosage: . During the same period patient was treated with PIRARUBICIN (View Pirarubicin Review and Pirarubicin Label ), VINDESINE (View Vindesine Review and Vindesine Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ).

4821092-1 | Abortion Complete, Abortion Missed, Acute Respiratory Distress Syndrome, Bone Marrow Failure, Post Procedural Complication, Sepsis, Stem Cell Transplant
Patient was taking Elspar (View Usage). Patient had the following side effects: abortion complete, abortion missed, acute respiratory distress syndrome, bone marrow failure, post procedural complication, sepsis (What is sepsis?), stem cell transplant on Oct 28, 2005 from NETHERLANDS Additional patient health information: Female patient , 30 years of age, was diagnosed with acute lymphocytic leukaemia and. Elspar dosage: . During the same period patient was treated with PREDNISONE (View Prednisone Review and Prednisone Label ), VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ), DAUNORUBICIN (View Daunorubicin Review and Daunorubicin Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).