Foliamin combined with Tocilizumab

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Liver Disorder Hospitalization 9/29/2008 Female 1/23/2009 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 9/29/2008 Female 2/20/2009 Physician Japan
Primary
Secondary
Concomitant
Still's Disease Adult Onset Hospitalization 9/29/2008 Female 2/27/2009 Physician Japan
Primary
Secondary
Concomitant
Still's Disease Adult Onset Hospitalization 9/29/2008 Female 1/4/2010 Physician Japan
Primary
Secondary
Concomitant
Eosinophilic Pneumonia Hospitalization 7/3/2009 Male 115 lb 1/21/2010 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Other Serious 11/16/2009 Female 1/21/2010 Physician Japan
Primary
Concomitant
Gastric Ulcer Other Serious 2/18/2009 Female 1/22/2010 Physician Japan
Primary
Secondary
Concomitant
Bronchopneumonia Other Serious 7/6/2009 Female 1/25/2010 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 9/29/2008 Female 130 lb 1/27/2010 Physician Japan
Primary
Concomitant
Septic Shock Life Threatening 12/25/2008 Female 1/27/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/21/2009 Female 2/1/2010 Physician Japan
Primary
Concomitant
Subcutaneous Abscess Hospitalization 4/22/2009 Female 139 lb 2/2/2010 Physician Japan
Primary
Concomitant
Lymphoma Hospitalization 9/22/2009 Female 99 lb 2/9/2010 Physician Japan
Primary
Secondary
Concomitant
Pyothorax Hospitalization 10/7/2009 61 Female 2/12/2010 Physician Japan
Primary
Concomitant
Dermatitis Bullous Hospitalization 4/26/2009 Female 126 lb 2/12/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Staphylococcal Other Serious 1/1/2009 Male 2/16/2010 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Hospitalization 1/5/2010 Female 2/16/2010 Physician Japan
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Other Serious 1/20/2010 Female 99 lb 2/17/2010 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Life Threatening 12/25/2008 Female 2/23/2010 Physician Japan
Primary
Secondary
Concomitant
Tonsillitis Hospitalization 9/5/2008 Female 2/23/2010 Physician Japan
Primary
Secondary
Concomitant
Subcutaneous Abscess Other Serious 10/16/2009 Female 2/25/2010 Other Health Professional Japan
Primary
Concomitant
Skin Ulcer Hospitalization 10/20/2008 Female 2/26/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/7/2009 61 Female 91 lb 2/26/2010 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 8/14/2009 Female 2/26/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 8/23/2009 Female 95 lb 3/3/2010 Physician Japan
Primary
Concomitant
Oedema Peripheral Hospitalization 10/2/2008 28 Female 112 lb 3/4/2010 Physician Japan
Primary
Secondary
Concomitant
Systemic Mycosis Hospitalization 3/10/2009 Female 3/4/2010 Physician Japan
Primary
Secondary
Concomitant
Lymphocyte Count Decreased Other Serious 10/7/2008 Female 117 lb 3/4/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 2/22/2010 Female 3/5/2010 Physician Japan
Primary
Concomitant
Uterine Cancer Hospitalization 12/21/2009 Female 99 lb 3/11/2010 Other Health Professional Japan
Primary
Secondary
Hepatic Function Abnormal Other Serious 8/7/2008 Female 105 lb 3/12/2010 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 9/16/2009 Female 132 lb 3/15/2010 Physician Japan
Primary
Secondary
Concomitant
Uterine Cancer Hospitalization 12/21/2009 47 Female 99 lb 5/21/2010 Other Health Professional Japan
Primary
Secondary
Hepatic Function Abnormal Other Serious 9/16/2009 53 Female 132 lb 5/25/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 8/14/2009 52 Female 5/27/2010 Physician Japan
Primary
Secondary
Concomitant
Skin Ulcer Hospitalization 2/3/2010 58 Female 170 lb 5/27/2010 Physician Japan
Primary
Concomitant
Hypercholesterolaemia Other Serious 11/10/2009 56 Female 5/27/2010 Physician Japan
Primary
Concomitant
Platelet Count Increased 7/6/2009 77 Female 5/28/2010 Physician Japan
Primary
Secondary
Concomitant
Synovitis Hospitalization 11/29/2009 67 Male 5/28/2010 Physician Japan
Primary
Concomitant
Lymphocyte Count Decreased Other Serious 1/4/2010 71 Female 73 lb 5/28/2010 Physician Japan
Primary
Secondary
Concomitant
Haematochezia Hospitalization 12/3/2009 68 Male 6/3/2010 Physician Japan
Primary
Concomitant
Peritonitis Bacterial Hospitalization 10/10/2009 78 Female 6/3/2010 Physician Japan
Primary
Secondary
Concomitant
Facial Palsy Other Serious 12/17/2008 47 Male 6/7/2010 Physician Japan
Primary
Concomitant
Vision Blurred Hospitalization 8/11/2009 62 Female 110 lb 6/8/2010 Physician Japan
Primary
Concomitant
Diffuse Large B-cell Lymphoma Stage Iii Life Threatening 7/1/2009 61 Female 137 lb 6/8/2010 Physician Japan
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 1/12/2010 61 Female 6/9/2010 Physician Japan
Primary
Concomitant
Pain In Extremity Life Threatening 7/1/2009 69 Female 112 lb 6/10/2010 Physician Japan
Primary
Concomitant
Hepatitis Acute Hospitalization 2/26/2009 43 Female 139 lb 6/15/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 5/11/2010 4 Female 6/18/2010 Physician Japan
Primary
Secondary
Concomitant
Sudden Hearing Loss Other Serious 5/20/2009 67 Female 97 lb 6/30/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 2/26/2009 43 Female 132 lb 6/30/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/2/2009 69 Female 122 lb 7/2/2010 Physician Japan
Primary
Secondary
Concomitant
Palpitations Other Serious 10/17/2008 37 Female 7/2/2010 Physician Japan
Primary
Concomitant
Palpitations Other Serious 10/17/2008 37 Female 7/6/2010 Physician Japan
Primary
Concomitant
Malaise Hospitalization 3/19/2009 51 Female 110 lb 7/9/2010 Physician Japan
Primary
Concomitant
Neutropenia Hospitalization 5/16/2010 4 Female 7/10/2010 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Hospitalization 1/5/2010 68 Female 7/10/2010 Physician Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 12/4/2009 66 Female 77 lb 7/13/2010 Physician Japan
Primary
Concomitant
Pruritus Hospitalization 1/16/2009 63 Female 130 lb 7/16/2010 Physician Japan
Primary
Secondary
Concomitant
Hepatitis Acute Hospitalization 2/26/2009 43 Female 132 lb 7/19/2010 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 10/30/2009 69 Female 126 lb 7/22/2010 Physician Japan
Primary
Concomitant
Retinal Detachment Hospitalization 12/28/2009 55 Male 118 lb 7/23/2010 Physician Japan
Primary
Secondary
Concomitant
Pancytopenia Other Serious 2/3/2010 57 Female 85 lb 7/28/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 2/22/2010 66 Female 7/29/2010 Physician Japan
Primary
Concomitant
Cerebral Infarction Hospitalization 4/2/2010 70 Female 134 lb 7/29/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 2/22/2010 66 Female 119 lb 7/30/2010 Physician Japan
Primary
Concomitant
Histiocytosis Haematophagic Hospitalization 7/21/2010 21 Female 8/3/2010 Physician Japan
Primary
Concomitant
Aortic Rupture Death Female 77 lb 8/5/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/27/2010 70 Female 8/5/2010 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 9/2/2008 47 Male 8/17/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Life Threatening 1/19/2009 73 Male 8/18/2010 Physician Japan
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 8/22/2008 73 Female 90 lb 8/25/2010 Physician Japan
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 9/18/2008 31 Female 8/27/2010 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 9/2/2008 47 Male 8/27/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Ileus Hospitalization 2/22/2010 66 Female 119 lb 8/30/2010 Physician Japan
Primary
Concomitant
Thyroid Neoplasm Hospitalization 9/1/2010 69 Female 172 lb 9/8/2010 Physician Japan
Primary
Concomitant
Sudden Hearing Loss Other Serious 5/20/2009 67 Female 97 lb 9/14/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Skin Ulcer Hospitalization 2/3/2010 58 Female 170 lb 9/16/2010 Physician Japan
Primary
Concomitant
Glomerulonephritis Acute Other Serious 3/16/2010 61 Female 126 lb 9/23/2010 Physician Japan
Primary
Concomitant
Agranulocytosis Hospitalization 7/6/2009 78 Female 132 lb 9/24/2010 Physician Japan
Primary
Concomitant
Hepatic Enzyme Increased Other Serious 9/18/2008 31 Female 9/27/2010 Physician Japan
Primary
Secondary
Concomitant
Palpitations Hospitalization 10/17/2008 37 Female 9/29/2010 Physician Japan
Primary
Concomitant
Pneumonia 10/30/2009 69 Female 126 lb 10/1/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased 2/3/2010 57 Female 85 lb 10/1/2010 Physician Japan
Primary
Concomitant
Vision Blurred Hospitalization 8/11/2009 62 Female 110 lb 10/4/2010 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 1/19/2009 73 Male 10/5/2010 Physician Japan
Primary
Concomitant
Retinal Detachment Hospitalization 10/13/2009 55 Male 118 lb 10/5/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 4/26/2009 76 Female 104 lb 10/6/2010 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Arthritis Other Serious 9/18/2008 31 Female 10/6/2010 Physician Japan
Primary
Secondary
Concomitant
Synovitis Hospitalization 11/29/2009 67 Male 10/8/2010 Physician Japan
Primary
Concomitant
Malaise Hospitalization 3/19/2009 51 Female 110 lb 10/8/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 1/19/2009 73 Male 10/12/2010 Physician Japan
Primary
Secondary
Concomitant
Viith Nerve Paralysis Other Serious 12/17/2008 47 Male 10/13/2010 Physician Japan
Primary
Concomitant
Melaena Other Serious 2/6/2009 82 Male 10/14/2010 Physician Japan
Primary
Concomitant
Thyroid Neoplasm Hospitalization 8/1/2010 69 Female 172 lb 10/15/2010 Other Health Professional Japan
Primary
Concomitant
Melaena Other Serious 2/6/2009 82 Male 10/19/2010 Physician Japan
Primary
Concomitant
Neoplasm Malignant Life Threatening 9/22/2008 53 Female 153 lb 10/19/2010 Physician Japan
Primary
Concomitant
Breast Cancer Hospitalization 11/8/2009 53 Female 10/21/2010 Physician Japan
Primary
Concomitant
Urinary Tract Infection Hospitalization 3/7/2009 47 Male 10/26/2010 Physician Japan
Primary
Concomitant
Tinea Manuum Hospitalization 2/17/2010 76 Female 10/28/2010 Physician Japan
Primary
Concomitant
Melaena Other Serious 2/6/2009 82 Male 10/28/2010 Physician Japan
Primary
Concomitant
Rheumatoid Arthritis Other Serious 9/18/2008 31 Female 11/9/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Hospitalization 3/1/2010 61 Female 134 lb 11/15/2010 Physician Japan
Primary
Concomitant
Spinal Compression Fracture Hospitalization 12/4/2009 66 Female 77 lb 11/16/2010 Physician Japan
Primary
Concomitant
Thyroid Neoplasm Hospitalization 8/11/2010 69 Female 181 lb 11/19/2010 Other Health Professional Japan
Primary
Concomitant
Tinea Manuum 2/17/2010 76 Female 11/22/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 1/19/2009 73 Male 11/23/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Cell Carcinoma Life Threatening 9/22/2008 53 Female 153 lb 12/1/2010 Physician Japan
Primary
Secondary
Concomitant
Uterine Cancer Hospitalization 12/21/2009 47 Female 99 lb 12/15/2010 Other Health Professional Japan
Primary
Secondary
Palpitations Other Serious 5/1/2010 42 Female 154 lb 12/17/2010 Other Health Professional Japan
Primary
Concomitant
Breast Cancer Female Hospitalization 10/8/2009 53 Female 12/28/2010 Physician Japan
Primary
Concomitant
Sudden Hearing Loss Hospitalization 5/20/2009 67 Female 97 lb 1/18/2011 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 3/3/2010 61 Female 134 lb 1/31/2011 Other Health Professional Japan
Primary
Concomitant
C-reactive Protein Increased Life Threatening 9/3/2010 63 Male 115 lb 1/31/2011 Physician Japan
Primary
Concomitant
Acute Respiratory Distress Syndrome Death 8/23/2009 70 Female 95 lb 2/3/2011 Physician Japan
Primary
Concomitant
Non-hodgkin's Lymphoma Hospitalization 9/22/2009 62 Female 99 lb 2/23/2011 Physician Japan
Primary
Secondary
Concomitant
Anaemia Life Threatening 9/3/2010 63 Male 115 lb 3/3/2011 Physician Japan
Primary
Concomitant
Pleurisy Death 8/30/2010 64 Male 3/7/2011 Other Health Professional Japan
Primary
Concomitant
Blood Creatinine Decreased Life Threatening 4/26/2009 76 Female 104 lb 3/16/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Arthritis Hospitalization 11/2/2010 5 Female 38 lb 3/17/2011 Physician Japan
Primary
Secondary
Concomitant
Liver Abscess Other Serious 12/17/2008 47 Male 4/5/2011 Other Health Professional Japan
Primary
Concomitant
Gastric Cancer Hospitalization 2/21/2012 70 Female 106 lb 5/29/2012 Physician Japan
Primary
Secondary
Concomitant
Gastric Cancer Hospitalization 2/21/2012 70 Female 106 lb 6/6/2012 Physician Japan
Primary
Secondary
Concomitant
Septic Shock Life Threatening 12/25/2008 73 Female 12/13/2012 Other Health Professional Country Not Specified
Primary
Secondary
Concomitant
Osteonecrosis Of Jaw Other Serious 1/12/2010 61 Female 6/21/2013 Physician Jp
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 9/2/2008 47 Male 2/4/2013 Country Not Specified
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Other Serious 1/29/2009 28 Female 117 lb 1/3/2013 Physician Country Not Specified
Primary
Secondary
Concomitant
Cell Marker Increased Other Serious 10/19/2010 77 Female 12/12/2012 Country Not Specified
Primary
Secondary
Concomitant
Juvenile Idiopathic Arthritis Hospitalization 10/24/2011 6 Female 33 lb 11/12/2012 Physician Jp
Primary
Concomitant
Spinal Compression Fracture Hospitalization 3/5/2009 65 Male 121 lb 3/14/2013 Physician Jp
Primary
Secondary
Concomitant
Atypical Pneumonia Hospitalization 3/8/2012 55 Male 3/6/2013 Physician Jp
Primary
Secondary
Concomitant
Joint Injury Hospitalization 7/13/2009 61 Female 86 lb 3/8/2013 Physician Jp
Primary
Secondary
Concomitant
Femur Fracture Other Serious 7/15/2010 73 Female 10/24/2012 Physician Jp
Primary
Concomitant
Spinal Ligament Ossification Hospitalization 7/2010 Male 11/23/2012 Physician Jp
Primary
Secondary
Concomitant
Calculus Ureteric Other Serious Male 11/19/2012 Physician Jp
Primary
Concomitant
Purulence Other Serious 9/6/2010 73 Female 11/6/2012 Physician Jp
Primary
Secondary
Concomitant
Nasopharyngitis Life Threatening 1/8/2011 74 Female 2/4/2013 Physician Jp
Primary
Secondary
Concomitant
Cerebral Infarction Hospitalization 11/4/2012 50 Male 1/2/2013 Physician Jp
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 5/11/2012 68 Female 108 lb 12/20/2012 Physician Jp
Primary
Concomitant
Interacting
Purulence Hospitalization 9/6/2010 73 Female 12/26/2012 Physician Jp
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 5/22/2009 61 Female 12/28/2012 Physician Jp
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/22/2012 30 Female 1/3/2013 Physician Jp
Primary
Secondary
Concomitant
Intestinal Perforation Hospitalization 9/2011 Female 3/14/2013 Physician Jp
Primary
Concomitant
Leiomyoma Hospitalization Female 1/8/2013 Physician Jp
Primary
Concomitant
Cholelithiasis Hospitalization 8/27/2012 79 Male 3/13/2013 Physician Jp
Primary
Concomitant
Pyrexia Other Serious 11/18/2008 16 Female 101 lb 3/7/2013 Physician Jp
Primary
Secondary
Concomitant
Purulence Hospitalization 1/22/2011 53 Female 3/7/2013 Physician Jp
Primary
Concomitant
Viith Nerve Paralysis Hospitalization 5/11/2012 74 Female 99 lb 3/12/2013 Physician Jp
Primary
Concomitant
Exposure During Pregnancy Other Serious Female 3/19/2013 Physician Jp
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 2/5/2009 64 Male 121 lb 3/21/2013 Physician Jp
Primary
Secondary
Concomitant