Clofarabine and mucosal inflammation Patient Reports March 20, 2010

Clofarabine Side Effects Report #5887331-3
Clofarabine side effect was reported by a Physician from UNITED STATES on Sept 10, 2008. Male patient, 48 years of age, was diagnosed with myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: agitation, mental status changes, mouth haemorrhage, mucosal inflammation, pharyngeal oedema. Clofarabine dosage: 56 MG, QD, INTRAVENOUS. During the same period patient was treated with BUSULFAN, FLUDARABINE PHOSPHATE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5578855-7
Clofarabine side effect was reported by a Physician from UNITED STATES on Dec 13, 2007. Male patient, 67 years of age, weighting 172.4 lb, was diagnosed with bone marrow conditioning regimen and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: aspartate aminotransferase increased, blood bilirubin increased, bone marrow transplant , dialysis , mucosal inflammation, neutropenic infection, renal failure. Clofarabine dosage: 54 MG, QDX5, INTRAVENOUS; 9 MG, ONCE, INTRAVENOUS. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5610402-3
Clofarabine side effect was reported by a Physician from UNITED STATES on Jan 21, 2008. Male patient, 67 years of age, weighting 172.4 lb, was diagnosed with bone marrow conditioning regimen and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: aspartate aminotransferase increased, blood bilirubin increased, blood stem cell transplant failure, dialysis , liver function test abnormal, mucosal inflammation, nausea , neutropenic infection, renal failure acute. Clofarabine dosage: 54 MG, QDX5, INTRAVENOUS. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5619795-4
Clofarabine side effect was reported by a Physician from UNITED STATES on Feb 01, 2008. Male patient, 67 years of age, weighting 172.4 lb, was diagnosed with bone marrow conditioning regimen and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: aspartate aminotransferase increased, blood bilirubin increased, blood stem cell transplant failure, dialysis , liver function test abnormal, mucosal inflammation, nausea , neutropenic infection, pain . Clofarabine dosage: 54 MG, QDX5, INTRAVENOUS. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE. Patient was hospitalized. Patient died on 01/21/2008.


Clofarabine Side Effects Report #5631594-6
Clofarabine side effect was reported by a Physician from UNITED STATES on Feb 08, 2008. Male patient, 67 years of age, weighting 172.4 lb, was diagnosed with bone marrow conditioning regimen and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: aspartate aminotransferase increased, blood stem cell transplant failure, dialysis , encephalopathy, liver function test abnormal, mucosal inflammation, nausea , neurological examination abnormal. Clofarabine dosage: 54 MG, QDX5, INTRAVENOUS. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE. Patient was hospitalized. Patient died on 01/21/2008.

Clofarabine Side Effects Report #5632634-0
Clofarabine side effect was reported by a Physician from UNITED STATES on Feb 12, 2008. Male patient, 67 years of age, weighting 172.4 lb, was diagnosed with bone marrow conditioning regimen and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: aspartate aminotransferase increased, blood bilirubin increased, blood stem cell transplant failure, depressed level of consciousness, dialysis , encephalopathy, liver function test abnormal, mucosal inflammation, neutropenic infection. Clofarabine dosage: 54 MG, QX5, INTRAVENOUS. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE. Patient was hospitalized. Patient died on 01/21/2008.

Clofarabine Side Effects Report #5407906-5
Clofarabine side effect was reported by a Physician from UNITED STATES on July 30, 2007. Male patient, 39 years of age, was diagnosed with bone marrow conditioning regimen and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: catheter sepsis, diarrhoea, disease progression, haemoptysis, hallucination, lower gastrointestinal haemorrhage, mucosal inflammation, renal failure acute. Clofarabine dosage: unknown. During the same period patient was treated with MELPHALAN, THIOTEPA. Patient was hospitalized. Patient died on 07/22/2007.

Clofarabine Side Effects Report #5701569-7
Clofarabine side effect was reported by a Health Professional from UNITED STATES on Apr 02, 2008. Male patient, 64 years of age, weighting 162.0 lb, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, dialysis , hepatotoxicity, hypotension, mucosal inflammation, renal failure, tachycardia, ventricular tachycardia. Clofarabine dosage: 40 MG/M2, QDX5, INTRAVENOUS. During the same period patient was treated with MELPHALAN. Patient recovered.

Clofarabine Side Effects Report #5713812-9
Clofarabine side effect was reported by a Health Professional from UNITED STATES on Apr 16, 2008. Male patient, 64 years of age, weighting 162.0 lb, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, dialysis , hepatotoxicity, hypotension, mucosal inflammation, nephropathy toxic, renal failure, ventricular tachycardia. Clofarabine dosage: 40 MG/M2, QDX5, INTRAVENOUS. During the same period patient was treated with MELPHALAN, LEVOFLOXACIN, CLONIDINE, HEPARIN, ACYCLOVIR, MORPHINE, PEPCID. Patient recovered.


Clofarabine Side Effects Report #5230396-2
Clofarabine side effect was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 18, 2007. Female patient, 57 years of age, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: diarrhoea, disseminated intravascular coagulation, mucosal inflammation, neutropenic sepsis, pneumonia , pulmonary haemorrhage, staphylococcal infection . Clofarabine dosage: 35 MG QD IV. During the same period patient was treated with CYTARABINE. Patient died on 12/07/2006.

Clofarabine Side Effects Report #5242685-6
Clofarabine side effect was reported by a Physician from UNITED KINGDOM on Jan 31, 2007. Female patient, 57 years of age, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: diarrhoea, disseminated intravascular coagulation, mucosal inflammation, neutropenic sepsis, pneumonia , pulmonary haemorrhage, staphylococcal infection . Clofarabine dosage: 20 MG/M2 QD IV. During the same period patient was treated with CYTARABINE. Patient died on 12/07/2006.

Clofarabine Side Effects Report #5287001-9
Clofarabine side effect was reported by a Consumer or non-health professional from UNITED KINGDOM on Mar 15, 2007. Female patient, 57 years of age, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: acute myeloid leukaemia recurrent, bacteria sputum identified, diarrhoea, disseminated intravascular coagulation, hypoxia, lower respiratory tract infection, lung infection, mucosal inflammation, neutropenic sepsis. Clofarabine dosage: 20 MG/M2 QD IV. During the same period patient was treated with CYTARABINE. Patient died on 12/07/2006.

Clofarabine Side Effects Report #5731076-7
Clofarabine side effect was reported by a Physician from UNITED STATES on Apr 28, 2008. Male patient, 54 years of age, weighting 163.8 lb, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: burning sensation, hyperbilirubinaemia, mucosal inflammation, renal failure acute, toxic epidermal necrolysis. Clofarabine dosage: 40 MG/M2, QDX5, INTRAVENOUS. During the same period patient was treated with THYMOGLOBULIN, VALTREX, ANIDULAFUNGIN, CEFEPIME, DEXAMETHASONE, NEXIUM, FAMOTIDINE, SINGULAIR. Patient recovered.

Clofarabine Side Effects Report #5733317-9
Clofarabine side effect was reported by a Physician from UNITED STATES on May 02, 2008. Male patient, 54 years of age, weighting 163.8 lb, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: asthenia, communication disorder, dyspnoea, hyperbilirubinaemia, mucosal inflammation, mucous membrane disorder, multi-organ failure, renal failure acute, restlessness. Clofarabine dosage: 40 MG/M2. QDX5, INTRAVENOUS. During the same period patient was treated with CYTARABINE, THYMOGLOBULIN, VALTREX, ANIDULAFUNGIN, CEFEPIME, DEXAMETHASONE, NEXIUM, FAMOTIDINE. Patient died on 04/28/2008.


Clofarabine Side Effects Report #5877501-2
Clofarabine side effect was reported by a Health Professional from UNITED STATES on Sept 04, 2008. Male patient, 54 years of age, weighting 163.8 lb, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: asthenia, blood culture positive, communication disorder, hepatic failure, mucosal dryness, mucosal haemorrhage, mucosal inflammation, mucous membrane disorder, multi-organ failure. Clofarabine dosage: 40 MG/M2, QDX5, INTRAVENOUS. During the same period patient was treated with CYTARABINE, THYMOGLOBULIN, VALTREX, ANIDULAFUNGIN, CEFEPIME, DEXAMETHASONE, NEXIUM. Patient died on 04/28/2008.

Clofarabine Side Effects Report #5909083-0
Clofarabine side effect was reported by a Physician from UNITED STATES on Sept 18, 2008. Male patient, 48 years of age, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: agitation, mental status changes, mouth haemorrhage, mucosal inflammation, oropharyngeal swelling. Clofarabine dosage: 56 MG; QD, INTRAVENOUS. During the same period patient was treated with BUSULFAN, FLUDARABINE PHOSPHATE. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5911671-2
Clofarabine side effect was reported by a Physician from UNITED STATES on Sept 30, 2008. Male patient, 48 years of age, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: acute graft versus host disease in liver, agitation, dialysis , mental status changes, mouth haemorrhage, mucosal inflammation, multi-organ failure, no therapeutic response, oedema mouth. Clofarabine dosage: 56 MG, QD, INTRAVENOUS. During the same period patient was treated with BUSULFAN, FLUDARABINE PHOSPHATE. Patient was hospitalized. Patient died on 09/25/2008.

Clofarabine Side Effects Report #5509076-1
Clofarabine side effect was reported by a Physician from UNITED STATES on Aug 08, 2007. Female patient, 46 years of age, was diagnosed with acute myeloid leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: mucosal inflammation. Clofarabine dosage: 22.5 MG/M2 QD X 5 IV. During the same period patient was treated with IDARUBICIN, CYTARABINE, COMPAZINE, DARVON, FAMOTIDINE, LEVAQUIN, SYNTHROID, PAXIL. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5704594-5
Clofarabine side effect 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 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.


Clofarabine Side Effects Report #5526441-7
Clofarabine side effect was reported by a Health Professional from UNITED STATES on Nov 21, 2007. Female patient, 38 years of age, weighting 163.8 lb, was diagnosed with acute lymphocytic leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: anuria, bacteria stool identified, blood culture positive, caecitis, dialysis , hypotension, mental status changes, mucosal inflammation, neutropenic colitis. Clofarabine dosage: 30 MG/M2 1XQD/5DAYS IV. During the same period patient was treated with MELPHALAN. Patient died on 11/17/2007.

Clofarabine Side Effects Report #5874647-X
Clofarabine side effect was reported by a Physician from FRANCE on Aug 20, 2008. Male patient, 22 years of age, weighting 110.2 lb, was diagnosed with acute lymphocytic leukaemia, palmar-plantar erythrodysaesthesia syndrome and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: aplasia, enterocolitis, mucosal inflammation, oedematous pancreatitis, palmar-plantar erythrodysaesthesia syndrome. Clofarabine dosage: 40 MG/M2, INTRAVENOUS. During the same period patient was treated with CYTARABINE, SULFADIAZINE. Patient recovered.

Clofarabine Side Effects Report #5878582-2
Clofarabine side effect was reported by a Physician from FRANCE on Aug 29, 2008. Male patient, 22 years of age, weighting 110.2 lb, was diagnosed with acute lymphocytic leukaemia, palmar-plantar erythrodysaesthesia syndrome and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: anaemia, aplasia, ascites, enterocolitis, mucosal inflammation, oedematous pancreatitis, palmar-plantar erythrodysaesthesia syndrome, platelet count decreased. Clofarabine dosage: 40 MG/M2, INTRAVENOUS. During the same period patient was treated with CYTARABINE, SULFADIAZINE. Patient recovered.

Clofarabine Side Effects Report #5375533-4
Clofarabine side effect was reported by a Physician from GERMANY on June 13, 2007. Male patient, 14 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: bone marrow failure, insomnia, mouth haemorrhage, mucosal inflammation, oral herpes, soft tissue necrosis, stomatitis. Clofarabine dosage: unknown. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #5019250-9
Clofarabine side effect was reported by a Physician from GERMANY on May 18, 2006. Male patient, 14 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: mucosal inflammation, stomatitis. Clofarabine dosage: unknown. Patient was hospitalized. Patient recovered.


Clofarabine Side Effects Report #4948286-9
Clofarabine side effect was reported by a Consumer or non-health professional from FRANCE on Mar 01, 2006. Female patient, 13 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with Clofarabine. After drug was administered, patient experienced the following side effects: anal ulcer, bronchopulmonary aspergillosis, febrile neutropenia, haemoglobin decreased, herpes simplex , lung disorder, mucosal inflammation, platelet count decreased, pleural effusion. Clofarabine dosage: 75 MG QD X 5 IV. Patient was hospitalized. Patient recovered.

Clofarabine Side Effects Report #4868845-1
Clofarabine side effect was reported by a Physician from SPAIN on Dec 14, 2005. Male patient, child 4 years of age, was treated with Clofarabine. After drug was administered, patient experienced the following side effects: bacterial infection , blood culture positive, bone pain, chills, hepatomegaly, hypoproteinaemia, mucosal inflammation, pyrexia, transaminases increased. Clofarabine dosage: unknown. During the same period patient was treated with CYTARABINE. Patient recovered.