Cyclosporine combined with Fludarabine Phosphate

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pneumonia Hospitalization 7/5/2005 58 Male 1/20/2006 Physician Japan
Primary
Secondary
Concomitant
Rales Other Serious 55 Female 2/9/2006 Physician France
Primary
Concomitant
Tracheostomy Life Threatening 20 Male 2/15/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Other Serious 45 Male 2/25/2006 Japan
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 45 Male 3/9/2006 Japan
Primary
Concomitant
Trichosporon Infection Other Serious 1/1/2004 30 Male 3/9/2006 Japan
Primary
Concomitant
Renal Impairment Other Serious 8/15/2005 21 Male 88 lb 3/10/2006 Japan
Primary
Concomitant
Visual Field Defect Other Serious 1/1/2005 49 Female 3/14/2006 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious Female 6/19/2006 Germany
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious Female 6/19/2006 Germany
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious Male 6/19/2006 Germany
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious Male 6/19/2006 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Other Serious Male 6/19/2006 Physician Germany
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious Female 6/19/2006 Physician Germany
Primary
Secondary
Concomitant
Sepsis Other Serious Male 6/19/2006 Germany
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious Male 6/19/2006 Germany
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious Male 6/19/2006 Germany
Primary
Secondary
Concomitant
Pneumonia Other Serious Female 6/19/2006 Germany
Primary
Secondary
Concomitant
Pneumonia Aspergillus Other Serious Female 6/19/2006 Germany
Primary
Secondary
Concomitant
Pneumonia Other Serious Male 6/19/2006 Germany
Primary
Secondary
Concomitant
Pneumonia Aspergillus Other Serious Male 6/19/2006 Germany
Primary
Secondary
Concomitant
Surgical Procedure Repeated Other Serious Male 6/19/2006 Germany
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious Male 6/19/2006 Germany
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious Female 6/19/2006 Germany
Primary
Secondary
Concomitant
Pneumonia Aspergillus Other Serious Female 6/19/2006 Germany
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious Male 6/19/2006 Germany
Primary
Secondary
Concomitant
Pneumonia Aspergillus Other Serious Female 6/19/2006 Germany
Primary
Secondary
Concomitant
Mucosal Inflammation Other Serious Female 6/19/2006 Germany
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 61 Male 7/15/2006 Physician United States
Primary
Secondary
Concomitant
Photosensitivity Reaction Other Serious 53 Male 7/15/2006 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 45 Male 7/15/2006 Physician United States
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 61 Female 7/14/2006 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 62 Male 7/14/2006 Physician United States
Primary
Secondary
Concomitant
Superficial Spreading Melanoma Stage Ii Other Serious 59 Male 7/15/2006 Physician United States
Primary
Concomitant
Mucosal Inflammation Other Serious Male 8/22/2006 Physician Germany
Primary
Secondary
Concomitant
Malignant Melanoma Other Serious 59 Male 10/12/2006 United States
Primary
Secondary
Malignant Melanoma Other Serious 53 Male 10/12/2006 United States
Primary
Secondary
Concomitant
Soft Tissue Infection Required Intervention 8/1/2006 59 Male 11/3/2006 Physician United States
Primary
Secondary
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 2/26/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Death 56 Female 2/16/2007 Germany
Primary
Secondary
Concomitant
Somnolence Death 56 Female 2/16/2007 Germany
Primary
Secondary
Concomitant
Renal Impairment Other Serious 56 Female 2/28/2007 Physician Germany
Primary
Secondary
Concomitant
Leukaemia Recurrent Death 63 Male 4/4/2007 France
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Other Serious Unknown 4/16/2007 Germany
Primary
Secondary
Stem Cell Transplant Other Serious 51 Female 5/8/2007 Other Health Professional Sweden
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Death 62 Male 5/15/2007 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Death 61 Male 5/15/2007 Physician United States
Primary
Secondary
Concomitant
Renal Tubular Disorder Death 7 Female 5/24/2007 Physician Italy
Primary
Secondary
Concomitant
Renal Tubular Disorder Other Serious 7 Female 5/30/2007 Physician Italy
Primary
Secondary
Concomitant
Malignant Melanoma Other Serious 53 Male 5/29/2007 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Death 62 Male 5/29/2007 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Death 61 Male 5/29/2007 Physician United States
Primary
Secondary
Concomitant
Miller Fisher Syndrome Other Serious 9 Female 6/19/2007 Other Health Professional Italy
Primary
Secondary
Concomitant
Miller Fisher Syndrome Other Serious 9 Female 6/19/2007 Other Health Professional Italy
Primary
Secondary
Reticulocyte Count Decreased Other Serious Male 6/23/2007 Japan
Primary
Secondary
Concomitant
Miller Fisher Syndrome Other Serious 9 Female 6/25/2007 Other Health Professional Italy
Primary
Secondary
Idiosyncratic Drug Reaction Other Serious 49 Female 6/20/2007 France
Primary
Concomitant
Treatment Failure Disability 9 Female 6/25/2007 Italy
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Other Serious 50 6/29/2007 Italy
Primary
Secondary
Concomitant
Miller Fisher Syndrome Other Serious 9 Female 7/5/2007
Primary
Secondary
Miller Fisher Syndrome Other Serious 9 Female 6/25/2007 Italy
Primary
Secondary
Vomiting Death 2/25/2007 13 Female 8/1/2007 Japan
Primary
Concomitant
Renal Tubular Disorder Other Serious 7 Female 8/14/2007 Physician Italy
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Death 5/6/2004 38 Female 128 lb 2/28/2005 Other Health Professional Poland
Primary
Concomitant
Staphylococcal Infection Death 12/1/2001 56 Female 168 lb 1/15/2007 Physician United States
Primary
Concomitant
Viraemia Other Serious 12 Male 9/21/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Stomatitis Life Threatening 5/6/2007 56 Female 9/18/2007 Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 12 Male 9/26/2007 Japan
Primary
Secondary
Concomitant
Erythema Multiforme Death 8/15/2007 Male 292 lb 10/6/2007 Consumer United States
Primary
Concomitant
Erythema Multiforme Death 8/15/2007 Male 292 lb 10/16/2007 Consumer United States
Primary
Concomitant
Renal Failure Acute Other Serious 28 Male 10/17/2007
Primary
Secondary
Concomitant
Ureaplasma Infection Hospitalization 28 Male 10/11/2007 Switzerland
Primary
Secondary
Stomatitis Other Serious 11/5/2006 55 Female 10/22/2007 Japan
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Other Serious 54 Male 10/25/2007 Physician Japan
Primary
Secondary
Concomitant
Ventricular Fibrillation Life Threatening 6/15/2007 35 Male 10/26/2007 Japan
Primary
Concomitant
Vasculitis Other Serious 15 Male 11/5/2007 Other Health Professional Canada
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Other Serious Male 11/7/2007 Japan
Primary
Secondary
Concomitant
Reticulocyte Count Decreased Other Serious Male 11/7/2007 Japan
Primary
Secondary
Concomitant
Systemic Candida Other Serious 26 Male 11/8/2007 Other Health Professional Germany
Primary
Secondary
Ureaplasma Infection Other Serious 28 Male 11/5/2007 Switzerland
Primary
Secondary
Concomitant
Hypertension Required Intervention 11 Male 11/5/2007 Saudi Arabia
Primary
Secondary
Ureaplasma Infection Other Serious 28 Male 11/23/2007 Physician Switzerland
Primary
Secondary
Concomitant
Systemic Candida Hospitalization 26 Male 11/15/2007 Germany
Primary
Secondary
Concomitant
Systemic Candida Hospitalization 26 Male 11/21/2007 Germany
Primary
Secondary
Concomitant
Renal Tubular Necrosis Other Serious 53 Male 12/6/2007 Other Health Professional Portugal
Primary
Secondary
Obliterative Bronchiolitis Death 25 Male 12/7/2007 Physician United Kingdom
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Other Serious 2/1/2001 52 Male 12/10/2007 Japan
Primary
Concomitant
Weight Decreased Other Serious 25 Male 12/11/2007 Other Health Professional United Kingdom
Primary
Secondary
Venous Thrombosis Other Serious 53 Male 12/7/2007 Physician Portugal
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 11/1/2006 53 Male 12/19/2007 Other Health Professional Japan
Primary
Concomitant
Systemic Candida Hospitalization 26 Male 12/19/2007 Germany
Primary
Secondary
Pyrexia Disability 7/21/2007 53 Female 119 lb 12/28/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Death 12 Male 1/9/2008 Germany
Primary
Secondary
Renal Failure Other Serious 12 Male 1/17/2008 Physician Germany
Primary
Secondary
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 11 Male 3/5/2008 Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Other Serious 39 Female 3/6/2008 Other Health Professional Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Other Serious 39 Female 3/17/2008 Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 11 Male 3/17/2008 Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 36 Female 3/28/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Distress Hospitalization 17 Male 3/28/2008 Consumer United States
Primary
Secondary
Concomitant
Vertigo Death 58 Male 3/29/2008 Physician Germany
Primary
Secondary
Septic Embolus Other Serious 7/17/2007 49 Male 4/2/2008 Japan
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 1/1/2004 58 Male 4/28/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Ventricular Extrasystoles Life Threatening 10/7/2007 57 Male 4/30/2008 Japan
Primary
Concomitant
Stomatitis Life Threatening 7/3/2007 51 Female 4/30/2008 Japan
Primary
Concomitant
Stem Cell Transplant Life Threatening 7/27/2007 43 Female 4/30/2008 Japan
Primary
Concomitant
Vomiting Life Threatening 5/28/2007 25 Male 4/30/2008 Japan
Primary
Concomitant
Weight Increased Death 9/13/2007 13 Male 4/30/2008 Japan
Primary
Concomitant
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 5/9/2008 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Other Serious 44 Male 5/9/2008 United States
Primary
Secondary
Vertigo Death Male 5/2/2008 Germany
Primary
Concomitant
Progressive Multifocal Leukoencephalopathy Hospitalization 1/1/2004 Male 5/15/2008 Other Health Professional Germany
Primary
Secondary
Pneumonia Bacterial Other Serious 4/9/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Hepatic Failure Other Serious 4/9/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 4/9/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Drug Toxicity Other Serious 4/9/2008 Germany
Primary
Secondary
White Blood Cell Count Increased Life Threatening 10/21/2007 46 Male 5/15/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 5/22/2008 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 5/29/2008 Iceland
Primary
Secondary
Concomitant
Treatment Related Secondary Malignancy Death 5/30/2008 United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 6/2/2008 Iceland
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 6/2/2008 Israel
Primary
Secondary
Concomitant
Treatment Related Secondary Malignancy Death 6/2/2008 United Kingdom
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 6/3/2008 Israel
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 51 Male 6/6/2008 France
Primary
Concomitant
Vertigo Death 67 Male 6/6/2008 Germany
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 44 Female 6/6/2008 France
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 44 Male 6/6/2008 Korea, Republic Of
Primary
Concomitant
Stomatitis Hospitalization 3/1/2007 62 Female 6/9/2008 Physician Japan
Primary
Concomitant
Vomiting 9/1/2007 18 Female 6/9/2008 Other Health Professional Japan
Primary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Other Serious 9 Female 6/13/2008 Germany
Primary
Secondary
Herpes Simplex Other Serious 18 Female 6/18/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Oral Herpes Other Serious 16 Female 6/18/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 57 6/26/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Vomiting Other Serious 1 Male 6/26/2008 United States
Primary
Secondary
Infection Death 6/26/2008 Spain
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 9 Female 6/25/2008 Other Health Professional Germany
Primary
Concomitant
Lymphoproliferative Disorder Death 17 6/30/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Weight Decreased Other Serious 21 Male 7/1/2008 Other Health Professional Germany
Primary
Concomitant
Stomatitis Other Serious 7/2/2008 Other Health Professional Germany
Primary
Concomitant
Weight Decreased Other Serious 21 Male 7/2/2008 Other Health Professional Germany
Primary
Concomitant
Vomiting Life Threatening 7/9/2007 50 Female 6/27/2008 Other Health Professional Japan
Primary
Concomitant
Pulmonary Toxicity Other Serious 7/3/2008 Germany
Primary
Secondary
Sepsis Other Serious 7/3/2008 Germany
Primary
Secondary
Venoocclusive Disease Other Serious 7/3/2008 Germany
Primary
Secondary
Pulmonary Toxicity Other Serious 7/7/2008 Germany
Primary
Secondary
Pulmonary Sepsis Life Threatening 6/1/2004 51 Male 7/7/2008 Other Health Professional Italy
Primary
Secondary
Concomitant
Retinal Haemorrhage Other Serious 26 Female 7/11/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Enterobacter Sepsis Hospitalization 8/21/2007 29 Male 7/8/2008 Japan
Primary
Concomitant