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BK VIRUS INFECTION side effect

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Sirolimus Side Effects Report #5633562-7
Health Professional from TURKEY reported SIROLIMUS problem on Feb 07, 2008. Female patient, child 12 years of age, was diagnosed with renal transplant and was treated with SIROLIMUS. After drug was administered, patient experienced the following problems/side effects: bk virus infection, blood creatinine increased, complications of transplanted kidney, dyspnoea, kidney transplant rejection, pericardial effusion, polyomavirus-associated nephropathy, pyrexia, renal impairment, . SIROLIMUS dosage: unknown. During the same period patient was treated with LEFLUNAMIDE, MYCOPHENOLATE MOFETIL, PREDNISOLONE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Sandimmune Side Effects Report #5581265-X
SANDIMMUNE problem was reported by a Consumer or non-health professional from JAPAN on Dec 27, 2007. Male patient, child 6 years of age, was diagnosed with stem cell transplant, bronchopulmonary aspergillosis and was treated with SANDIMMUNE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, blood creatinine increased, cytomegalovirus antigen positive, febrile neutropenia, stomatitis, . SANDIMMUNE dosage: 60 MG/D. During the same period patient was treated with AMPHOTERICIN B, FLUDARABINE PHOSPHATE, ANTITHYMOCYTE IMMUNOGLOBULIN, CYCLOPHOSPHAMIDE, IRRADIATION, METHOTREXATE, VORICONAZOLE, BLOOD TRANSFUSION. Patient recovered.

Cyclosporine Side Effects Report #5564552-0
Consumer or non-health professional from JAPAN reported CYCLOSPORINE problem on Dec 12, 2007. Male patient, child 6 years of age, was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, cytomegalovirus antigen positive, febrile neutropenia, stomatitis, . CYCLOSPORINE dosage: unknown. Patient recovered.

Cyclosporine Side Effects Report #5572873-0
CYCLOSPORINE problem was reported by a Consumer or non-health professional from JAPAN on Dec 18, 2007. Male patient, child 6 years of age, was diagnosed with stem cell transplant, bronchopulmonary aspergillosis and was treated with CYCLOSPORINE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, cytomegalovirus antigen positive, febrile neutropenia, stomatitis, . CYCLOSPORINE dosage: unknown. During the same period patient was treated with AMPHOTERICIN B, FLUDARABINE, ANTITHYMOCYTE IMMUNOGLOBULIN, CYCLOPHOSPHAMIDE, IRRADIATION, METHOTREXATE, VORICONAZOLE, BLOOD TRANSFUSION. Patient recovered.


Prograf Side Effects Report #5578706-0
Physician from JAPAN reported PROGRAF problem on Dec 12, 2007. Male patient, 24 years of age, was diagnosed with renal transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: bk virus infection, convulsion, diffuse large b-cell lymphoma recurrent, gastroenteritis escherichia coli, hepatic function abnormal, histiocytosis haematophagic, kaposi's varicelliform eruption, metastases to central nervous system, platelet count decreased, . PROGRAF dosage: unknown. During the same period patient was treated with PREDNISONE, MYCOPHENOLATE MOFETIL. Patient was hospitalized. Patient recovered.

Erl Side Effects Report #5474089-5
ERL problem was reported by a Physician from AUSTRALIA on Sept 19, 2007. Male patient, 43 years of age, weighting 173.7 lb, was diagnosed with renal transplant and was treated with ERL. After drug was administered, patient experienced the following problems/side effects: bk virus infection, blood creatinine increased, nephropathy toxic, renal vessel disorder, . ERL dosage: 720 MG, BID. During the same period patient was treated with NEORAL. Patient was hospitalized. Patient recovered.

Efavirenz Side Effects Report #5441750-8
Health Professional from UNITED STATES reported EFAVIRENZ problem on Aug 23, 2007. Male patient, 43 years of age, was diagnosed with acquired immunodeficiency syndrome and was treated with EFAVIRENZ. After drug was administered, patient experienced the following problems/side effects: bk virus infection, confusional state, coordination abnormal, dysarthria, encephalitis, gait disturbance, headache, memory impairment, speech disorder, . EFAVIRENZ dosage: unknown. During the same period patient was treated with ETHAMBUTOL HYDROCHLORIDE, FLUCONAZOLE, ISONIAZID, LAMIVUDINE, OFLOXACIN, PYRAZINAMIDE, ZIDOVUDINE, SULFAMETHOXAZOLE AND TRIMETHOPRIM. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5404992-3
CLOFARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on July 18, 2007. Female patient, child 9 years of age, weighting 55.56 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, cytomegalovirus infection, epistaxis, febrile neutropenia, haematocrit decreased, haemoglobin decreased, human herpes virus 6 serology positive, pancreatitis, platelet count decreased, . CLOFARABINE dosage: 30 MG/M2 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Certican Side Effects Report #5417787-1
Physician from AUSTRALIA reported CERTICAN problem on Aug 08, 2007. Male patient, 43 years of age, weighting 173.7 lb, was diagnosed with prophylaxis against transplant rejection, renal transplant and was treated with CERTICAN. After drug was administered, patient experienced the following problems/side effects: bk virus infection, blood creatinine increased, nephropathy toxic, renal vessel disorder, . CERTICAN dosage: 720 MG, BID. During the same period patient was treated with NEORAL. Patient was hospitalized. Patient recovered.


Zidovudine Side Effects Report #5421796-6
ZIDOVUDINE problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 06, 2007. Male patient, 43 years of age, was diagnosed with hiv infection and was treated with ZIDOVUDINE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, cerebral toxoplasmosis, encephalitis, . ZIDOVUDINE dosage: unknown. During the same period patient was treated with LAMIVUDINE, EFAVIRENZ, COMBIVIR, FLUCONAZOLE, COTRIM, ISONIAZID. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5444088-8
Physician from UNITED STATES reported CLOFARABINE problem on Aug 17, 2007. Female patient, child 8 years of age, weighting 42.99 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, bladder disorder, crystal urine present, heart rate increased, incontinence, nasal congestion, neutrophil count decreased, . CLOFARABINE dosage: 32 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, ZOFRAN, ATIVAN, FILGRASTIM. Patient was hospitalized. Patient recovered.

Rituximab Side Effects Report #5384257-9
RITUXIMAB problem was reported by a Consumer or non-health professional from SWEDEN on July 05, 2007. Male patient was diagnosed with renal transplant and was treated with RITUXIMAB. After drug was administered, patient experienced the following problems/side effects: bk virus infection, . RITUXIMAB dosage: 800 MG, SINGLE. During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Rituximab Side Effects Report #5384257-9
Consumer or non-health professional from SWEDEN reported RITUXIMAB problem on July 05, 2007. Male patient was diagnosed with renal transplant and was treated with RITUXIMAB. After drug was administered, patient experienced the following problems/side effects: bk virus infection, . RITUXIMAB dosage: 800 MG, SINGLE. During the same period patient was treated with TACROLIMUS, MYCOPHENOLATE MOFETIL, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5794297-3
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on June 13, 2008. Male patient, child 5 years of age, weighting 40.12 lb, was diagnosed with t-cell type acute leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, cystitis haemorrhagic, febrile neutropenia, gastrointestinal mucosal disorder, haematuria, ultrasound bladder abnormal, . CLOFARABINE dosage: 15 MG, QDX5, INTRAVENOUS. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, DAPSONE, NEUPOGEN, CIPROFLOXACIN, FLUCONAZOLE. Patient was hospitalized. Patient recovered.


Prograf Side Effects Report #5354881-8
Physician from UNITED STATES reported PROGRAF problem on May 31, 2007. Male patient, 17 years of age, was diagnosed with kidney transplant rejection and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: bk virus infection, bladder distension, kidney transplant rejection, nephrotic syndrome, tubulointerstitial nephritis, urethral stenosis, . PROGRAF dosage: unknown. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5371436-X
CLOFARABINE problem was reported by a Physician from UNITED STATES on June 12, 2007. Female patient, child 8 years of age, weighting 42.99 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, blood pressure diastolic decreased, blood urine present, crystal urine present, dysuria, haematuria, heart rate increased, micturition urgency, nasal congestion, . CLOFARABINE dosage: 32 MG QD X 5 IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, ZOFRAN, ATIVAN, FILGRASTIM. Patient was hospitalized. Patient recovered.

Abatacept Side Effects Report #5321142-2
Health Professional from PORTUGAL reported ABATACEPT problem on May 08, 2007. Male patient, 68 years of age, was diagnosed with rheumatoid arthritis and was treated with ABATACEPT. After drug was administered, patient experienced the following problems/side effects: bk virus infection, pulmonary tuberculosis, . ABATACEPT dosage: unknown. During the same period patient was treated with METHOTREXATE, PREDNISONE, NAPROXEN, FOLIC ACID. Patient was hospitalized. Patient recovered.

Tacrolimus Side Effects Report #5323497-1
TACROLIMUS problem was reported by a Health Professional from UNITED STATES on Apr 19, 2007. Male patient, 67 years of age, was diagnosed with renal transplant and was treated with TACROLIMUS. After drug was administered, patient experienced the following problems/side effects: bk virus infection, cardiac arrest, cardiomegaly, chest pain, cholecystitis acute, chronic allograft nephropathy, gallbladder disorder, haematocrit decreased, haematuria, . TACROLIMUS dosage: 1.00 MG, BID; ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, SIROLIMUS, INSULIN, ZOCOR, METOPROLOL TARTRATE. Patient was hospitalized. Patient died on 05/26/2005.

Erl Side Effects Report #5290439-7
Physician from AUSTRALIA reported ERL problem on Mar 28, 2007. Male patient, 43 years of age, weighting 173.7 lb, was diagnosed with prophylaxis against transplant rejection, renal transplant and was treated with ERL. After drug was administered, patient experienced the following problems/side effects: bk virus infection, blood creatinine increased, renal vessel disorder, . ERL dosage: 720 MG, BID. During the same period patient was treated with NEORAL. Patient was hospitalized. Patient recovered.


Certican Side Effects Report #5311228-0
CERTICAN problem was reported by a Physician from AUSTRALIA on Apr 18, 2007. Male patient, 43 years of age, weighting 173.7 lb, was diagnosed with prophylaxis against transplant rejection, renal transplant and was treated with CERTICAN. After drug was administered, patient experienced the following problems/side effects: bk virus infection, blood creatinine increased, nephropathy toxic, . CERTICAN dosage: 720 MG, BID. During the same period patient was treated with NEORAL. Patient was hospitalized. Patient recovered.

Abatacept Side Effects Report #5254868-X
Health Professional from PORTUGAL reported ABATACEPT problem on Feb 23, 2007. Male patient, 68 years of age, was diagnosed with rheumatoid arthritis and was treated with ABATACEPT. After drug was administered, patient experienced the following problems/side effects: bk virus infection, pulmonary tuberculosis, . ABATACEPT dosage: unknown. During the same period patient was treated with METHOTREXATE, PREDNISONE, NAPROXEN, FOLIC ACID. Patient was hospitalized. Patient recovered.

Methotrexate Side Effects Report #5262373-X
METHOTREXATE problem was reported by a Consumer or non-health professional from AUSTRALIA on Feb 21, 2007. Male patient, 25 years of age, was diagnosed with non-hodgkin's lymphoma and was treated with METHOTREXATE. After drug was administered, patient experienced the following problems/side effects: bk virus infection, cerebral haemorrhage, cerebral infarction, haematuria, myelopathy, sepsis, . METHOTREXATE dosage: unknown. During the same period patient was treated with CYTARABINE, CYCLOPHOSPHAMIDE, VINCRISTINE. Patient died.

Procrit Side Effects Report #5510518-6
Physician from UNITED STATES reported PROCRIT problem on Oct 25, 2007. Male patient, 42 years of age, was diagnosed with renal failure chronic, neutropenia and was treated with PROCRIT. After drug was administered, patient experienced the following problems/side effects: aplasia pure red cell, bk virus infection, cytomegalovirus antibody positive, haemodialysis, hernia, kidney transplant rejection, neutropenia, weight decreased, . PROCRIT dosage: unknown. During the same period patient was treated with NEUPOGEN, PROGRAF, MYCOPHENOLATE MOFETIL, LANTUS, PHOSLO, NORVASC, PROTONIX, CLONIDINE. Patient was hospitalized. Patient recovered.

Tacrolimus Side Effects Report #5409597-6
TACROLIMUS problem was reported by a Health Professional from UNITED KINGDOM on July 23, 2007. Male patient, 67 years of age, was diagnosed with renal transplant and was treated with TACROLIMUS. After drug was administered, patient experienced the following problems/side effects: abdominal pain, bk virus infection, cardiac arrest, cardiomegaly, cholecystitis acute, complications of transplanted kidney, disease recurrence, haematuria, haemodialysis, . TACROLIMUS dosage: 1.00 MG, BID, ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, SIROLIMUS, INSULIN, ZOCOR, METOPROLOL TARTRATE. Patient was hospitalized. Patient died on 05/26/2005.

Prograf Side Effects Report #5442413-5
Physician from UNITED STATES reported PROGRAF problem on Aug 17, 2007. Male patient, 34 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: adenovirus infection, bk virus infection, blood bicarbonate decreased, blood chloride increased, blood magnesium decreased, cytomegalovirus infection, fanconi syndrome, polyomavirus-associated nephropathy, renal failure acute, . PROGRAF dosage: unknown. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient recovered.

Busulfex Side Effects Report #5744161-0
BUSULFEX problem was reported by a Consumer or non-health professional from JAPAN on May 08, 2008. Male patient, 15 years of age, was diagnosed with stem cell transplant and was treated with BUSULFEX. After drug was administered, patient experienced the following problems/side effects: anorexia, bk virus infection, bone marrow transplant, cytomegalovirus infection, diarrhoea, febrile neutropenia, graft versus host disease, haematuria, jaundice, . BUSULFEX dosage: unknown. During the same period patient was treated with NEUPOGEN. Patient recovered.

Prograf Side Effects Report #5692637-7
Physician from UNITED STATES reported PROGRAF problem on Mar 21, 2008. Female patient, child 4 years of age, was diagnosed with liver transplant and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: adenovirus infection, bk virus infection, bone marrow disorder, bone marrow failure, colitis, disease progression, enteritis, haematuria, intestinal obstruction, . PROGRAF dosage: unknown. During the same period patient was treated with CORTICOSTEROID NOS. Patient recovered.

Clofarabine Side Effects Report #5704594-5
CLOFARABINE problem was reported by a Health Professional from UNITED STATES on Mar 27, 2008. Female patient, child 9 years of age, weighting 53.57 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: atelectasis, bk virus infection, candidiasis, culture stool positive, cystitis haemorrhagic, febrile neutropenia, mucosal inflammation, pancreatitis, sinusitis, . CLOFARABINE dosage: 30 MG/M2, IV; 20 G/M2, IV; 20 MG/M2, QD, IV-SEE IMAGE. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Tacrolimus Side Effects Report #5705530-8
Health Professional from FRANCE reported TACROLIMUS problem on Mar 26, 2008. Male patient, 75 years of age, was diagnosed with renal transplant and was treated with TACROLIMUS. After drug was administered, patient experienced the following problems/side effects: anorexia, bk virus infection, blood creatinine increased, blood urea increased, dehydration, dialysis, hypernatraemia, leukocytosis, lung disorder, . TACROLIMUS dosage: unknown. During the same period patient was treated with NEORAL, CELLCEPT, PREDNISONE, CATAPRES, AMLODIPINE BESYLATE, IMUREL. Patient was hospitalized. Patient recovered.

Tacrolimus Side Effects Report #5348494-1
TACROLIMUS problem was reported by a Health Professional from UNITED KINGDOM on May 27, 2007. Male patient, 67 years of age, was diagnosed with renal transplant and was treated with TACROLIMUS. After drug was administered, patient experienced the following problems/side effects: abdominal pain, bk virus infection, cardiac arrest, cardiomegaly, cholecystitis acute, haematuria, hypertensive emergency, pneumonia, post procedural complication, . TACROLIMUS dosage: 1.00 MG, BID, ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, SIROLIMUS, INSULIN, ZOCOR, METOPROLOL TARTRATE. Patient was hospitalized. Patient died on 05/26/2005.

Busulfex Side Effects Report #5356575-1
Health Professional from JAPAN reported BUSULFEX problem on May 29, 2007. Female patient, 13 years of age, was diagnosed with stem cell transplant and was treated with BUSULFEX. After drug was administered, patient experienced the following problems/side effects: adenovirus infection, bk virus infection, blood culture positive, bone marrow transplant, diarrhoea, enterococcal infection, fungal infection, histiocytosis haematophagic, hydronephrosis, . BUSULFEX dosage: unknown. During the same period patient was treated with VALPROATE. Patient died on 03/28/2007.

Methotrexate Side Effects Report #5361314-4
METHOTREXATE problem was reported by a Physician from AUSTRALIA on June 06, 2007. Male patient, 25 years of age, was diagnosed with non-hodgkin's lymphoma and was treated with METHOTREXATE. After drug was administered, patient experienced the following problems/side effects: areflexia, bk virus infection, bone marrow disorder, cerebral haemorrhage, cerebral infarction, csf protein increased, febrile neutropenia, gastrointestinal haemorrhage, graft versus host disease, . METHOTREXATE dosage: unknown. During the same period patient was treated with CYTARABINE. Patient was hospitalized and became disabled. Patient recovered.

Clofarabine Side Effects Report #5374043-8
Health Professional from UNITED STATES reported CLOFARABINE problem on June 13, 2007. Female patient, child 9 years of age, weighting 55.56 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anorexia, bk virus infection, cytomegalovirus infection, depression, epistaxis, febrile neutropenia, haematocrit decreased, haemoglobin decreased, human herpes virus 6 serology positive, . CLOFARABINE dosage: 30 MG/M2 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Methotrexate Side Effects Report #5284343-8
METHOTREXATE problem was reported by a Consumer or non-health professional from AUSTRALIA on Mar 22, 2007. Male patient, 25 years of age, was diagnosed with non-hodgkin's lymphoma and was treated with METHOTREXATE. After drug was administered, patient experienced the following problems/side effects: areflexia, bk virus infection, cerebral haemorrhage, cerebral infarction, csf protein increased, febrile neutropenia, gastrointestinal haemorrhage, haematuria, no therapeutic response, . METHOTREXATE dosage: 12 MG IT. During the same period patient was treated with CYTARABINE, IDARUBICIN, FLUDARABINE. Patient died.

Vincristine Side Effects Report #5605994-4
Physician from FRANCE reported VINCRISTINE problem on Jan 15, 2008. Male patient, 17 years of age, was diagnosed with b-cell lymphoma and was treated with VINCRISTINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, aplasia, bk virus infection, cholestasis, haematuria, hepatic lesion, hepatosplenic candidiasis, immune reconstitution syndrome, . VINCRISTINE dosage: unknown. During the same period patient was treated with PREDNISONE, DOXORUBICIN, METHOTREXATE, CYTARABINE, ETOPOSIDE, CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5536030-6
PROGRAF problem was reported by a Physician from UNITED STATES on Nov 19, 2007. Male patient, 42 years of age, was diagnosed with renal transplant, nephrogenic anaemia, cytomegalovirus infection, antibiotic prophylaxis and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: anaemia, aplasia pure red cell, bk virus infection, bone marrow failure, cytomegalovirus test positive, diverticulum, haemodialysis, hernia pain, kidney transplant rejection, . PROGRAF dosage: unknown. During the same period patient was treated with PROCRIT, GANCICLOVIR, DAPSONE, MYCOPHENOLATE MOFETIL, LANTUS, PHOSLO, NORVASC, PROTONIX. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5569900-3
Consumer or non-health professional from UNITED STATES reported CLOFARABINE problem on Dec 05, 2007. Female patient, child 9 years of age, weighting 55.56 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anorexia, atelectasis, bk virus infection, blood culture positive, bone marrow transplant, cytomegalovirus infection, depression, disease progression, epistaxis, . CLOFARABINE dosage: 30 MG/M2 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5510568-X
CLOFARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 23, 2007. Female patient, child 9 years of age, weighting 55.56 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anorexia, atelectasis, bk virus infection, breath sounds abnormal, cytomegalovirus viraemia, depression, epistaxis, febrile neutropenia, haematocrit decreased, . CLOFARABINE dosage: 30 MG/M2 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5523546-1
Physician from GERMANY reported CYTARABINE problem on Nov 06, 2007. Male patient, 24 years of age, was diagnosed with acute lymphocytic leukaemia, graft versus host disease and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease in intestine, acute graft versus host disease in skin, bk virus infection, complications of transplant surgery, cystitis haemorrhagic, hepatotoxicity, . CYTARABINE dosage: unknown. During the same period patient was treated with CYCLOSPORINE, PURINE ANALOGUES. Patient recovered.

Busulfex Side Effects Report #5385511-7
BUSULFEX problem was reported by a Health Professional from JAPAN on June 26, 2007. Female patient, 13 years of age, was diagnosed with stem cell transplant and was treated with BUSULFEX. After drug was administered, patient experienced the following problems/side effects: adenovirus infection, anorexia, bk virus infection, bladder disorder, bone marrow transplant, diarrhoea, enterococcal infection, fungal infection, haematoma, . BUSULFEX dosage: unknown. During the same period patient was treated with VALPROATE. Patient died on 03/28/2007.

Clofarabine Side Effects Report #5391845-2
Physician from UNITED STATES reported CLOFARABINE problem on July 06, 2007. Female patient, child 9 years of age, weighting 55.56 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anorexia, atelectasis, bk virus infection, cytomegalovirus infection, depression, epistaxis, febrile neutropenia, haematocrit decreased, haemoglobin decreased, . CLOFARABINE dosage: 30 MG/M2 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Busulfex Side Effects Report #5385511-7
BUSULFEX problem was reported by a Health Professional from JAPAN on June 26, 2007. Female patient, 13 years of age, was diagnosed with stem cell transplant and was treated with BUSULFEX. After drug was administered, patient experienced the following problems/side effects: adenovirus infection, anorexia, bk virus infection, bladder disorder, bone marrow transplant, diarrhoea, enterococcal infection, fungal infection, haematoma, . BUSULFEX dosage: unknown. During the same period patient was treated with VALPROATE. Patient died on 03/28/2007.

Clofarabine Side Effects Report #5391845-2
Physician from UNITED STATES reported CLOFARABINE problem on July 06, 2007. Female patient, child 9 years of age, weighting 55.56 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: anorexia, atelectasis, bk virus infection, cytomegalovirus infection, depression, epistaxis, febrile neutropenia, haematocrit decreased, haemoglobin decreased, . CLOFARABINE dosage: 30 MG/M2 IV. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5320804-0
CLOFARABINE problem was reported by a Physician from UNITED STATES on Apr 23, 2007. Male patient, 40 years of age, weighting 223.1 lb, was diagnosed with acute lymphocytic leukaemia and was treated with CLOFARABINE. After drug was administered, patient experienced the following problems/side effects: adenovirus infection, alanine aminotransferase increased, bk virus infection, blood alkaline phosphatase increased, chronic sinusitis, culture urine positive, disease progression, febrile neutropenia, haematuria, . CLOFARABINE dosage: 34 MG DAILY IV. During the same period patient was treated with CLOPARABINE, CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient died on 02/20/2007.

Prograf Side Effects Report #5259838-3
Physician from UNITED STATES reported PROGRAF problem on Feb 22, 2007. Male patient, 51 years of age, was diagnosed with prophylaxis and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease in intestine, acute graft versus host disease in skin, bk virus infection, bronchopulmonary aspergillosis, cystitis haemorrhagic, grand mal convulsion, lymphopenia, positron emission tomogram abnormal, progressive multifocal leukoencephalopathy, . PROGRAF dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient died.