Cyclophosphamide combined with Neoral

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
White Blood Cell Count Increased Other Serious 7/1/2005 14 Male 3/21/2006 Japan
Primary
Secondary
Trichosporon Infection Other Serious 1/1/2004 30 Male 3/29/2006 Japan
Primary
Secondary
Concomitant
Urine Sodium Increased Other Serious 9 Male 7/28/2006 Other Health Professional Japan
Primary
Concomitant
Weight Decreased Hospitalization 12/30/2004 75 Male 8/2/2006 Physician France
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 1/1/2002 32 Female 9/5/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Decreased Other Serious 51 Male 9/21/2006 France
Primary
Secondary
Concomitant
Epstein-barr Virus Infection Other Serious 8/1/2005 67 Male 10/6/2006 Japan
Primary
Concomitant
Pregnancy Congenital Anomaly 0 10/11/2006 Physician Japan
Primary
Secondary
Spleen Disorder Other Serious 8/1/2005 67 Male 10/13/2006 Japan
Primary
Concomitant
Serum Ferritin Increased Other Serious 4 Female 10/23/2006 Japan
Primary
Secondary
Concomitant
Truncus Arteriosus Persistent Hospitalization 0 11/7/2006 Physician Japan
Primary
Secondary
Mucous Stools Other Serious 4 Female 1/3/2007 Japan
Primary
Concomitant
Thrombophlebitis Other Serious 1/1/2003 34 Female 1/5/2007 Japan
Primary
Secondary
Concomitant
Weight Decreased Other Serious 12/1/2004 49 Male 2/10/2007 Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 2/19/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 2/19/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 86 lb 2/23/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 2/19/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 3/22/2006 73 Female 2/28/2007 Japan
Primary
Secondary
Viral Pharyngitis Other Serious 8/26/2005 19 Male 5/11/2007 Poland
Primary
Secondary
Concomitant
Sinusitis Fungal Hospitalization 62 Male 6/11/2007 Japan
Primary
Secondary
Concomitant
Sinusitis Fungal Hospitalization 62 Male 6/11/2007 Japan
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
Viral Dna Test Positive Other Serious 7/11/2004 15 Male 73 lb 6/22/2007 Japan
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 10/31/2004 63 Male 7/5/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 10/31/2004 63 Male 7/17/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 2/5/2007 46 Female 10/27/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 2/5/2007 46 Female 10/27/2007 Japan
Primary
Secondary
Concomitant
Renal Transplant Other Serious 11/1/2005 22 Female 12/21/2007 Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 2/7/2008 Physician United States
Primary
Secondary
Concomitant
Eosinophilia Other Serious 2/7/2008 Physician United States
Primary
Secondary
Concomitant
Skin Erosion Other Serious 1/1/1997 60 Male 2/26/2008 Japan
Primary
Concomitant
Cardiac Disorder Hospitalization 8/15/2007 Female 165 lb 2/27/2008 Physician United Kingdom
Primary
Concomitant
Weight Increased Other Serious 11/1/2005 55 Male 3/13/2008 Japan
Primary
Concomitant
Toxic Encephalopathy Other Serious 1/1/2003 11 Male 3/18/2008 Physician Japan
Primary
Concomitant
Weight Decreased Hospitalization 3/13/2008 47 Male 141 lb 5/14/2008 Physician Japan
Primary
Secondary
Concomitant
Post Procedural Infection Hospitalization 8/15/2007 Female 165 lb 6/11/2008 Physician United Kingdom
Primary
Concomitant
Toxic Encephalopathy Other Serious 9/12/2006 5 Male 6/16/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 3/13/2008 47 Male 141 lb 6/24/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 3/13/2008 47 Male 141 lb 7/2/2008 Physician Japan
Primary
Secondary
Concomitant
Pneumothorax Other Serious 20 Female 8/28/2008 Other Health Professional Japan
Primary
Concomitant
Subcutaneous Emphysema Other Serious 5/1/2005 49 Female 9/8/2008 Other Health Professional Japan
Primary
Concomitant
Subcutaneous Emphysema Other Serious 5/1/2005 49 Female 9/8/2008 Other Health Professional Japan
Primary
Concomitant
Varices Oesophageal Other Serious 6/1/2002 43 Female 10/29/2008 Other Health Professional Japan
Primary
Concomitant
Varices Oesophageal Other Serious 6/1/2002 43 Female 10/29/2008 Other Health Professional Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious 6/1/2007 26 Female 11/18/2008 Other Health Professional Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious 6/1/2007 26 Female 11/18/2008 Other Health Professional Japan
Primary
Concomitant
Pyrexia Other Serious 20 Female 11/19/2008 Other Health Professional Japan
Primary
Concomitant
Engraftment Syndrome Other Serious 10 Female 12/1/2008 Japan
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 1/1/2006 Female 118 lb 12/29/2008 Other Health Professional Japan
Primary
Concomitant
Engraftment Syndrome Other Serious 4/1/2008 10 Female 1/15/2009 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 42 Female 2/13/2009 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 42 Female 2/13/2009 Physician Japan
Primary
Concomitant
Sclerema Other Serious 10/1/2004 2/18/2009 Physician Japan
Primary
Secondary
Concomitant
Engraftment Syndrome Other Serious 4/1/2008 10 Female 2/23/2009 Japan
Primary
Secondary
Concomitant
Varicella Other Serious 1/1/2003 21 Male 2/27/2009 Other Health Professional Japan
Primary
Concomitant
Varicella Other Serious 1/1/2003 21 Male 2/27/2009 Other Health Professional Japan
Primary
Concomitant
Toxic Encephalopathy Other Serious 5/2/2007 Female 104 lb 3/6/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 5/2/2007 Female 104 lb 3/6/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 1/1/2003 11 Male 3/24/2009 Japan
Primary
Concomitant
Pyrexia Hospitalization 9/1/2008 48 Male 4/1/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Sinusitis Hospitalization 2/26/2008 16 Male 117 lb 4/3/2009 Physician Japan
Primary
Concomitant
Toxic Encephalopathy Other Serious 1/1/2003 11 Female 4/4/2009 Japan
Primary
Concomitant
Sinusitis Hospitalization 2/26/2008 16 Male 117 lb 4/6/2009 Physician Japan
Primary
Concomitant
Splenic Neoplasm Malignancy Unspecified Other Serious 11/24/2005 Male 154 lb 4/8/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 9/22/2008 61 Female 93 lb 4/9/2009 Physician Japan
Primary
Secondary
Concomitant
Sinusitis Hospitalization 1/1/2008 16 Male 117 lb 4/14/2009 Physician Japan
Primary
Concomitant
Swollen Tongue Other Serious 1/1/2007 16 Male 4/24/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 7/1/2008 59 Female 7/9/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 7/1/2008 59 Female 7/9/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 8/7/2007 Male 181 lb 7/20/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 7/1/2008 Female 93 lb 7/22/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 7/1/2008 Female 93 lb 8/3/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 8/18/2008 26 Female 117 lb 8/5/2009 Physician Japan
Primary
Secondary
Concomitant
Splenic Neoplasm Malignancy Unspecified Other Serious 6/18/2005 Male 154 lb 9/8/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 9/10/2008 61 Female 93 lb 9/11/2009 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 8/18/2008 26 Female 117 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Cholelithiasis Hospitalization 12/25/2007 30 Male 145 lb 10/12/2009 Physician Japan
Primary
Secondary
Concomitant
Vertigo Other Serious 4/1/2007 27 Female 99 lb 12/21/2009 Other Health Professional Japan
Primary
Concomitant
Vomiting Other Serious 7/1/2008 Female 93 lb 2/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 6/8/2008 2 Male 3/1/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 6/8/2008 2 Male 3/3/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 7/1/2008 Female 93 lb 3/22/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 7/17/2007 Male 62 lb 3/22/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 7/3/2009 Male 174 lb 3/25/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 7/3/2009 Male 174 lb 3/30/2010 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 11/27/2007 59 Male 3/30/2010 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 2/28/2007 36 Female 5/20/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 2/28/2007 36 Female 5/20/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 6/29/2009 14 Female 7/23/2010 Japan
Primary
Concomitant
Systemic Inflammatory Response Syndrome Life Threatening 12/15/2009 54 Male 8/9/2010 Physician United States
Primary
Secondary
Concomitant
Tubulointerstitial Nephritis Other Serious 2 Male 8/10/2010 Other Health Professional Japan
Primary
Concomitant
Sicca Syndrome Other Serious 7/1/2009 48 Male 9/22/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sicca Syndrome Other Serious 7/1/2009 48 Male 9/22/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Systemic Inflammatory Response Syndrome Life Threatening 12/15/2009 54 Male 10/6/2010 Physician United States
Primary
Secondary
Concomitant
Stenotrophomonas Sepsis Other Serious 8/11/2009 58 Female 10/20/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Splenic Infarction Death 40 Female 137 lb 1/20/2011 Other Health Professional Japan
Primary
Concomitant
Engraftment Syndrome Other Serious 4/16/2010 17 Male 1/26/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Creatinine Increased Hospitalization 4/16/2010 17 Male 143 lb 2/9/2011 Physician Japan
Primary
Concomitant
Decreased Appetite Hospitalization 11/1/2010 54 Female 3/25/2011 Other Health Professional France
Primary
Secondary
Concomitant
Coma Hospitalization 11/1/2010 53 Male 4/7/2011 Other Health Professional France
Primary
Secondary
Engraftment Syndrome Other Serious 1/3/2010 20 Male 4/20/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Lung Adenocarcinoma Hospitalization 1/1/2006 69 Male 4/25/2011 Other Health Professional France
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Other Serious 7/24/2008 57 Male 174 lb 4/26/2011 Other Health Professional Japan
Primary
Concomitant
Aplastic Anaemia Hospitalization 1/9/2009 44 Male 223 lb 4/27/2011 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Leukoencephalopathy Death 1/29/2011 59 Female 5/4/2011 Other Health Professional France
Primary
Secondary
Oesophageal Ulcer Haemorrhage Other Serious 7/24/2008 57 Male 174 lb 7/6/2011 Other Health Professional Japan
Primary
Concomitant
Dysphagia Other Serious 55 Male 7/14/2011 Other Health Professional France
Primary
Secondary
Concomitant
C-reactive Protein Increased Death 10/21/2009 74 Male 7/21/2011 Consumer Japan
Primary
Secondary
Concomitant
Neutrophil Count Increased Other Serious 1/1/2002 10 Male 8/11/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Cytomegalovirus Viraemia Life Threatening 11/22/2004 31 Female 8/26/2011 Physician Japan
Primary
Secondary
Concomitant
Hyperbilirubinaemia Death 12/15/2004 31 Female 8/31/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Rash Hospitalization 10/20/2009 64 Male 9/12/2011 Physician Japan
Primary
Secondary
Concomitant
Overdose Hospitalization 38 Female 9/16/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Other Serious 49 Female 110 lb 9/17/2011 Other Health Professional China
Primary
Concomitant
Pneumonia Death 10/21/2009 74 Male 9/29/2011 Consumer Japan
Primary
Secondary
Concomitant
Blood Creatinine Increased Other Serious 9/16/2011 49 Female 10/31/2011 Other Health Professional France
Primary
Concomitant
Renal Impairment Other Serious 16 Female 75 lb 10/31/2011 Physician Algeria
Primary
Secondary
Drug Ineffective Other Serious 16 Female 75 lb 11/10/2011 Physician Algeria
Primary
Secondary
Cytomegalovirus Viraemia Hospitalization 12/15/2004 31 Female 11/14/2011 Japan
Primary
Secondary
Concomitant
Neutrophil Count Increased Death 7/23/2010 58 Male 143 lb 11/18/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Death 7/23/2010 58 Male 143 lb 11/18/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 9/22/2011 50 Male 11/22/2011 Other Health Professional France
Primary
Secondary
Concomitant
Blood Creatinine Increased Hospitalization 9/22/2011 50 Male 11/22/2011 Other Health Professional France
Primary
Secondary
Concomitant
Capillary Leak Syndrome Hospitalization 9/26/2011 50 Male 11/23/2011 Other Health Professional France
Primary
Secondary
Concomitant
Cardiac Failure Acute Hospitalization 10/21/2009 74 Male 12/1/2011 Physician Japan
Primary
Secondary
Concomitant
Photosensitivity Reaction Death 10/20/2009 64 Male 12/19/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 10/1/2011 44 Female 2/7/2012 Physician Japan
Primary
Concomitant
Atrial Flutter Death 6/16/2009 61 Male 3/13/2012 Physician Japan
Primary
Secondary
Concomitant
Insomnia Death 1/24/2011 63 Male 3/19/2012 Physician Japan
Primary
Secondary
Concomitant
Disorientation Life Threatening 1/15/2012 45 Female 3/28/2012 Other Health Professional France
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Death 6/16/2009 61 Male 3/30/2012 Physician Japan
Primary
Secondary
Concomitant
Confusional State Life Threatening 1/14/2012 45 Female 4/2/2012 Other Health Professional France
Primary
Secondary
Fungaemia Life Threatening 1/14/2012 45 Female 4/3/2012 Other Health Professional France
Primary
Secondary
Extensor Plantar Response Death 1/15/2012 45 Female 4/3/2012 Other Health Professional France
Primary
Secondary
Concomitant
Blood Creatinine Increased Death 1/15/2012 45 Female 4/3/2012 Other Health Professional France
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 1/1/2011 74 Female 5/2/2012 Other Health Professional Japan
Primary
Concomitant
Pain In Extremity Other Serious 1/1/2011 24 Female 5/7/2012 Physician France
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 1/1/2011 24 Female 5/11/2012 Physician France
Primary
Secondary
Concomitant
Dyskinesia Life Threatening 1/14/2012 45 Female 5/16/2012 Other Health Professional France
Primary
Secondary
Oropharyngeal Pain Death 52 Female 5/22/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Dyskinesia Life Threatening 1/14/2012 45 Female 132 lb 5/23/2012 Other Health Professional France
Primary
Secondary
Flatulence Other Serious 5/21/2007 18 Male 132 lb 7/3/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Decreased Appetite Death 11/30/2009 63 Male 7/16/2012 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Hypertension Disability 8/1/2011 45 Female 7/24/2012 Other Health Professional Japan
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 6/28/2012 70 Male 7/25/2012 Physician Japan
Primary
Concomitant
Respiratory Distress Disability 8/1/2011 45 Female 7/23/2012 Other Health Professional Japan
Primary
Concomitant
Polyneuropathy Other Serious Female 7/26/2012 Physician Japan
Primary
Secondary
Concomitant
Polyneuropathy Other Serious 37 Female 7/26/2012 Pharmacist Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 64 Male 7/27/2012 Other Health Professional Japan
Primary
Concomitant