Busulfex and disease recurrence Patient Reports February 13, 2012

Busulfex Side Effects Report #6091275-4
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 69 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , disease progression, disease recurrence, myelodysplastic syndrome, refractory anaemia with an excess of blasts, stem cell transplant. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient recovered.

Busulfex Side Effects Report #6030743-8
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Dec 24, 2008. Male patient, 65 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease, anorexia, bone marrow transplant , bone marrow transplant rejection, disease recurrence, malignant neoplasm progression, platelet count decreased, pneumonia , stomatitis. Busulfex dosage: 8 ML, QID INTRAVENOUS. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, FILGRASTIM, METHOTREXATE, TACROLIMUS. Patient was hospitalized. Patient died on 01/05/2008.

Busulfex Side Effects Report #5990194-9
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Nov 27, 2008. Female patient, 64 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: anorexia, blood bilirubin increased, cardiac failure chronic, disease recurrence, febrile neutropenia, hypoaesthesia, hypokalaemia, hyponatraemia, malaise. Busulfex dosage: 6.6 ML, TID. During the same period patient was treated with FLUDARABINE PHOSPHATE, DEPAKENE, ANTILYMPHOCYTE IMMUNOGLOBULIN, FILGRASTIM, METHOTREXATE, TACROLIMUS, VANCOMYCIN HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Busulfex Side Effects Report #5698228-6
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Mar 21, 2008. Male patient, 58 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: disease recurrence, myelodysplastic syndrome, sepsis . Busulfex dosage: unknown. Patient died on 06/22/2007.


Busulfex Side Effects Report #5729839-7
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Apr 21, 2008. Female patient, 55 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease, altered state of consciousness, anorexia, cytomegalovirus infection , disease recurrence, disseminated intravascular coagulation, encephalitis , encephalopathy, malaise. Busulfex dosage: 18 ML, INTRAVENOUS; 24 ML, INTRAVENOUS; 6 ML, INTRAVENOUS. During the same period patient was treated with CYCLOPHOSPHAMIDE, PHENYTOIN, NARTOGRASTIN, NEUPOGEN, LENOGRASTIM, METHOTREXATE. Patient was hospitalized. Patient died.

Busulfex Side Effects Report #6092953-3
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Female patient, 52 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: chronic graft versus host disease, cytomegalovirus infection , disease progression, disease recurrence, liver disorder, oral disorder, skin disorder, stem cell transplant. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient recovered.

Busulfex Side Effects Report #6091299-7
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 50 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: chronic graft versus host disease, cytomegalovirus infection , disease progression, disease recurrence, liver disorder, skin disorder, stem cell transplant, treatment failure. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient recovered.

Busulfex Side Effects Report #6092946-6
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Female patient, 43 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , disease progression, disease recurrence, pancytopenia, sepsis , stem cell transplant. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient died.

Busulfex Side Effects Report #6092927-2
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 41 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , disease progression, disease recurrence, stem cell transplant, therapeutic response decreased. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, ANTITHYMOCYTE IMMUNOGLUBULIN. Patient recovered.


Busulfex Side Effects Report #6091304-8
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Female patient, 38 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia, disease progression, disease recurrence, herpes zoster, pneumonia , stem cell transplant. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient recovered.

Busulfex Side Effects Report #6092928-4
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 36 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , disease progression, disease recurrence. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient died.

Busulfex Side Effects Report #6092930-2
Busulfex side effect was reported by a Physician from KOREA, REPUBLIC OF on Feb 11, 2009. Female patient, 36 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia, disease progression, disease recurrence, stem cell transplant. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient died.

Busulfex Side Effects Report #6092926-0
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 28 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: disease progression, disease recurrence, graft versus host disease, infection , pancytopenia, weight decreased. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient died.

Busulfex Side Effects Report #6091301-2
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 27 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease in skin, cytomegalovirus infection , disease progression, disease recurrence, pneumonia staphylococcal, staphylococcal sepsis, stem cell transplant. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient died.


Busulfex Side Effects Report #6092929-6
Busulfex side effect was reported by a Physician from KOREA, REPUBLIC OF on Feb 11, 2009. Female patient, 26 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease, acute graft versus host disease in liver, chronic graft versus host disease, cytomegalovirus infection , disease progression, disease recurrence, herpes zoster. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient died.

Busulfex Side Effects Report #6091256-0
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 24 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia, cytomegalovirus infection , disease progression, disease recurrence, stem cell transplant. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient recovered.

Busulfex Side Effects Report #6092945-4
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 23 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , disease recurrence, herpes zoster, stem cell transplant. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient recovered.

Busulfex Side Effects Report #6092932-6
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 22 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , disease recurrence, pseudomembranous colitis. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient recovered.

Busulfex Side Effects Report #6065341-3
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Jan 18, 2009. Female patient, child 2 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: bone marrow failure, cardiac failure, coagulopathy, disease recurrence, hypovolaemia, ileus paralytic, intestinal obstruction. Busulfex dosage: 14 MG, QID INTRAVENOUS. During the same period patient was treated with MELPHALAN, METHYLPREDNISOLONE. Patient was hospitalized and became disabled. Patient recovered.


Busulfex Side Effects Report #6092947-8
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Female patient, 19 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: cytomegalovirus infection , disease progression, disease recurrence, pancytopenia, pneumocystis jiroveci pneumonia, rash , sepsis , stem cell transplant. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient died.

Busulfex Side Effects Report #6091263-8
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 16 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease in skin, acute lymphocytic leukaemia, disease progression, disease recurrence, stem cell transplant. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient died.

Busulfex Side Effects Report #6092944-2
Busulfex side effect was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Feb 11, 2009. Male patient, 16 years of age, was diagnosed with stem cell transplant and was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease in intestine, chronic graft versus host disease, cytomegalovirus infection , disease progression, disease recurrence. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, THYMOGLOBULIN. Patient died.

Busulfex Side Effects Report #5729829-4
Busulfex side effect was reported by a Consumer or non-health professional from JAPAN on Apr 21, 2008. Female patient, 51 years of age, was treated with Busulfex. After drug was administered, patient experienced the following side effects: acute graft versus host disease, bone marrow transplant rejection, disease recurrence, haemorrhage, herpes virus infection, liver disorder, myelodysplastic syndrome, pneumonia , respiratory disorder. Busulfex dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, NEUPOGEN, METHOTREXATE, CYCLOSPORINE, WARFARINPOTASSIUM. Patient died.