Afinitor combined with Sorafenib Tosilate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
White Blood Cell Count Increased Other Serious 5/24/2010 56 Male 7/21/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 6/15/2010 62 Male 126 lb 8/13/2010 Physician Japan
Primary
Concomitant
Respiratory Disorder Hospitalization 6/29/2010 68 Female 115 lb 8/13/2010 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 7/5/2010 60 Male 8/16/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 5/24/2010 56 Male 8/24/2010 Physician Japan
Primary
Concomitant
Stomatitis Hospitalization 5/1/2010 69 Male 9/3/2010 Physician Japan
Primary
Concomitant
Pulmonary Embolism Other Serious 6/8/2010 63 Male 143 lb 9/6/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 5/18/2010 71 Male 9/7/2010 Physician Japan
Primary
Concomitant
Skin Ulcer Other Serious 7/5/2010 76 Female 99 lb 9/7/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 7/1/2010 45 Male 132 lb 9/8/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 8/16/2010 74 Male 159 lb 9/23/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 5/31/2010 62 Male 126 lb 9/24/2010 Physician Japan
Primary
Concomitant
Stomatitis Life Threatening 7/8/2010 65 Male 146 lb 9/29/2010 Physician Japan
Primary
Concomitant
Pneumonia Bacterial Other Serious 6/8/2010 48 Male 10/4/2010 Physician Japan
Primary
Concomitant
Stomatitis Life Threatening 6/23/2010 65 Male 146 lb 10/7/2010 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 7/5/2010 60 Male 10/11/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 6/11/2010 76 Male 99 lb 10/11/2010 Physician Japan
Primary
Concomitant
Respiratory Disorder Hospitalization 6/29/2010 68 Female 115 lb 10/11/2010 Physician Japan
Primary
Concomitant
Pleurodesis Other Serious Male 10/14/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 8/16/2010 74 Male 159 lb 10/15/2010 Physician Japan
Primary
Concomitant
Respiratory Distress Other Serious 6/8/2010 63 Male 143 lb 10/20/2010 Physician Japan
Primary
Concomitant
Glycosylated Haemoglobin Increased Other Serious Male 123 lb 10/20/2010 Physician Japan
Primary
Concomitant
Osteomyelitis Other Serious 6/2/2010 45 Male 10/20/2010 Physician Japan
Primary
Secondary
Concomitant
Respiratory Distress Death 6/8/2010 63 Male 143 lb 10/26/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 8/21/2010 78 Male 10/26/2010 Physician Japan
Primary
Concomitant
Pulmonary Oedema Other Serious 9/15/2010 69 Male 130 lb 10/28/2010 Physician Japan
Primary
Concomitant
Malaise Hospitalization 8/10/2010 76 Male 123 lb 10/29/2010 Physician Japan
Primary
Concomitant
Urticaria Other Serious 9/24/2010 58 Male 11/5/2010 Physician Japan
Primary
Concomitant
Skin Ulcer Other Serious 7/5/2010 76 Female 99 lb 11/5/2010 Physician Japan
Primary
Concomitant
Hyperglycaemia Other Serious 9/6/2010 76 Male 11/10/2010 Physician Japan
Primary
Concomitant
Thoracic Cavity Drainage Other Serious 6/10/2010 28 Female 99 lb 11/11/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 5/31/2010 62 Male 126 lb 11/12/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 3/20/2010 60 Male 11/15/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 9/24/2010 66 Male 11/16/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Hospitalization 9/11/2010 61 Female 11/16/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 7/1/2010 45 Male 132 lb 11/17/2010 Physician Japan
Primary
Concomitant
Respiratory Disorder Hospitalization 6/29/2010 68 Female 115 lb 11/19/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 8/14/2010 59 Male 11/22/2010 Physician Japan
Primary
Concomitant
Pneumonia Other Serious 9/1/2010 78 Female 11/24/2010 Physician Japan
Primary
Concomitant
Pleurodesis Other Serious 6/30/2010 58 Male 172 lb 11/25/2010 Physician Japan
Primary
Concomitant
Stomatitis Hospitalization 5/2/2010 69 Male 11/29/2010 Physician Japan
Primary
Concomitant
Eczema Other Serious 6/4/2010 74 Male 159 lb 11/30/2010 Physician Japan
Primary
Concomitant
Metastatic Renal Cell Carcinoma Other Serious 9/24/2010 52 Female 11/30/2010 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 7/30/2010 54 Male 11/30/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 11/1/2010 70 Male 11/30/2010 Physician Japan
Primary
Concomitant
Haemoglobin Decreased Other Serious Male 11/30/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 6/28/2010 59 Male 11/30/2010 Physician Japan
Primary
Concomitant
Thrombocytopenia Other Serious 5/6/2010 83 Male 11/30/2010 Other Health Professional Japan
Primary
Concomitant
Blood Amylase Increased Other Serious Male 170 lb 11/30/2010 Other Health Professional Japan
Primary
Concomitant
Respiratory Distress Other Serious 7/28/2010 63 Male 134 lb 11/30/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 6/11/2010 76 Male 99 lb 12/2/2010 Physician Japan
Primary
Concomitant
Disseminated Intravascular Coagulation Hospitalization 11/18/2010 59 Male 132 lb 12/2/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 8/21/2010 78 Male 12/8/2010 Physician Japan
Primary
Concomitant
Pulmonary Oedema Other Serious 9/15/2010 69 Male 130 lb 12/10/2010 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 7/30/2010 54 Male 12/14/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 8/31/2010 55 Male 12/14/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 5/6/2010 40 Female 95 lb 12/14/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 9/16/2010 75 Male 119 lb 12/16/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 10/5/2010 64 Male 119 lb 12/20/2010 Physician Japan
Primary
Concomitant
Malaise Life Threatening 10/14/2010 59 Male 132 lb 12/20/2010 Physician Japan
Primary
Concomitant
Haematocrit Increased Other Serious 9/9/2010 63 Male 123 lb 12/21/2010 Physician Japan
Primary
Concomitant
Pleural Effusion Other Serious 6/30/2010 58 Male 172 lb 12/22/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 8/16/2010 74 Male 159 lb 12/23/2010 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Life Threatening 10/16/2010 67 Male 141 lb 12/23/2010 Physician Japan
Primary
Concomitant
Stomatitis Life Threatening 6/23/2010 65 Male 146 lb 12/28/2010 Physician Japan
Primary
Concomitant
Platelet Count Increased Other Serious 7/5/2010 63 Female 126 lb 12/29/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 8/16/2010 74 Male 159 lb 12/29/2010 Physician Japan
Primary
Concomitant
Thrombocytopenia Other Serious 5/6/2010 83 Male 12/29/2010 Other Health Professional Japan
Primary
Concomitant
Respiratory Disorder Other Serious 8/23/2010 61 Male 12/30/2010 Physician Japan
Primary
Concomitant
Vitreous Haemorrhage Other Serious 10/19/2010 69 Male 12/31/2010 Pharmacist Japan
Primary
Concomitant
Hyperglycaemia Other Serious 8/14/2010 59 Male 1/6/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Hospitalization 8/21/2010 78 Male 1/7/2011 Physician Japan
Primary
Concomitant
Cough Hospitalization 5/18/2010 71 Male 1/7/2011 Physician Japan
Primary
Concomitant
Blood Potassium Decreased Other Serious 7/12/2010 73 Male 134 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Malaise Hospitalization 10/14/2010 59 Male 132 lb 1/10/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Other Serious 6/25/2010 75 Male 1/21/2011 Physician Japan
Primary
Concomitant
C-reactive Protein Increased Hospitalization 8/10/2010 76 Male 123 lb 1/24/2011 Physician Japan
Primary
Concomitant
Blood Glucose Increased Other Serious 11/1/2010 63 Male 1/24/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Hospitalization 9/11/2010 61 Female 1/25/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Perforation Hospitalization 8/31/2010 55 Male 1/25/2011 Physician Japan
Primary
Secondary
Concomitant
Eczema Other Serious 6/4/2010 74 Male 159 lb 1/31/2011 Physician Japan
Primary
Concomitant
Pneumonia Aspiration Other Serious Male 2/2/2011 Physician Japan
Primary
Concomitant
Alanine Aminotransferase Increased Hospitalization 9/27/2010 78 Female 2/2/2011 Physician Japan
Primary
Concomitant
Intestinal Obstruction Hospitalization 12/21/2010 77 Male 2/4/2011 Physician Japan
Primary
Concomitant
Blood Glucose Increased Other Serious 6/4/2010 74 Male 159 lb 1/31/2011 Physician Japan
Primary
Concomitant
Respiratory Distress Hospitalization 7/28/2010 63 Male 134 lb 2/11/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Perforation Hospitalization 1/24/2011 66 Female 2/11/2011 Physician Japan
Primary
Concomitant
Malaise Other Serious 5/6/2010 40 Female 95 lb 2/14/2011 Physician Japan
Primary
Concomitant
Disseminated Intravascular Coagulation Life Threatening 10/14/2010 59 Male 132 lb 2/15/2011 Physician Japan
Primary
Concomitant
Hypokalaemia Other Serious 7/5/2010 63 Female 126 lb 2/15/2011 Physician Japan
Primary
Concomitant
Eczema Other Serious 6/4/2010 74 Male 159 lb 2/15/2011 Physician Japan
Primary
Concomitant
Hyperglycaemia Hospitalization 6/28/2010 59 Male 2/17/2011 Physician Japan
Primary
Concomitant
Skin Disorder Other Serious 1/27/2011 72 Female 123 lb 2/22/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Amylase Increased Other Serious 10/13/2010 55 Male 170 lb 2/23/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Other Serious 11/1/2010 70 Male 2/24/2011 Physician Japan
Primary
Concomitant
Gamma-glutamyltransferase Increased Hospitalization 10/21/2010 61 Female 2/28/2011 Physician Japan
Primary
Concomitant
C-reactive Protein Increased Other Serious 7/23/2010 77 Male 3/3/2011 Consumer Japan
Primary
Concomitant
Stomatitis Other Serious 9/30/2010 74 Female 3/3/2011 Physician Japan
Primary
Concomitant
Blood Lactate Dehydrogenase Increased Other Serious 10/21/2010 31 Male 3/4/2011 Physician Japan
Primary
Concomitant
Liver Disorder Other Serious 12/8/2010 73 Male 176 lb 3/7/2011 Physician Japan
Primary
Concomitant
Pneumonia Fungal Death 10/14/2010 59 Male 132 lb 3/7/2011 Physician Japan
Primary
Concomitant
Platelet Count Decreased Hospitalization 5/6/2010 68 Male 3/8/2011 Physician Japan
Primary
Concomitant
Gastrointestinal Perforation Other Serious 8/31/2010 55 Male 3/9/2011 Physician Japan
Primary
Secondary
Concomitant
Delirium Hospitalization 10/14/2010 59 Male 132 lb 3/14/2011 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 10/29/2010 79 Male 3/16/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Other Serious 7/5/2010 76 Female 99 lb 3/21/2011 Physician Japan
Primary
Concomitant
Pleural Effusion Death 10/14/2010 59 Male 132 lb 3/23/2011 Physician Japan
Primary
Concomitant
Blood Potassium Decreased Hospitalization 7/12/2010 73 Male 134 lb 3/25/2011 Physician Japan
Primary
Secondary
Concomitant
Neoplasm Malignant Life Threatening 11/2/2010 59 Male 137 lb 3/25/2011 Physician Japan
Primary
Concomitant
Insomnia Hospitalization 4/23/2010 56 Female 97 lb 3/28/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Other Serious 9/16/2010 75 Male 119 lb 3/30/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Other Serious 1/27/2011 72 Female 123 lb 4/1/2011 Physician Japan
Primary
Secondary
Concomitant
Generalised Oedema Other Serious 12/14/2010 78 Male 4/6/2011 Physician Japan
Primary
Concomitant
Death Death 9/24/2010 80 Female 4/6/2011 Physician Japan
Primary
Concomitant
Blood Creatine Phosphokinase Increased Other Serious 1/11/2011 73 Male 4/8/2011 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Stage Iv Hospitalization 8/31/2010 55 Male 4/8/2011 Physician Japan
Primary
Secondary
Concomitant
Neoplasm Malignant Death Female 4/8/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 5/14/2010 71 Male 137 lb 4/11/2011 Physician Japan
Primary
Concomitant
C-reactive Protein Increased Hospitalization 9/6/2010 76 Male 4/11/2011 Physician Japan
Primary
Concomitant
Malaise Hospitalization 10/19/2010 74 Male 4/11/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Hospitalization 6/27/2010 71 Male 4/12/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Other Serious 9/3/2010 28 Female 4/12/2011 Physician Japan
Primary
Concomitant
Blood Alkaline Phosphatase Increased Hospitalization 6/28/2010 59 Male 4/13/2011 Physician Japan
Primary
Concomitant
Anaemia Death 9/3/2010 28 Female 4/15/2011 Physician Japan
Primary
Concomitant
Gamma-glutamyltransferase Increased Other Serious 1/4/2011 81 Male 4/18/2011 Physician Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Hospitalization 1/21/2011 67 Male 4/19/2011 Physician Japan
Primary
Concomitant
Alanine Aminotransferase Increased Hospitalization 10/21/2010 61 Female 4/19/2011 Physician Japan
Primary
Concomitant
Lymphocyte Count Decreased Other Serious 7/5/2010 63 Female 126 lb 4/20/2011 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 6/25/2010 75 Male 4/22/2011 Physician Japan
Primary
Concomitant
Meningitis Other Serious 7/13/2010 70 Male 117 lb 4/26/2011 Physician Japan
Primary
Secondary
Concomitant
Metastases To Lung Other Serious 5/14/2010 71 Male 137 lb 4/26/2011 Physician Japan
Primary
Concomitant
Haemoglobin Decreased Other Serious 1/19/2011 62 Male 4/27/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Other Serious 8/16/2010 74 Male 159 lb 4/29/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Other Serious Male 5/4/2011 Physician Japan
Primary
Concomitant
Epistaxis Other Serious 12/15/2010 53 Male 5/5/2011 Physician Japan
Primary
Concomitant
Blood Glucose Increased Other Serious 6/4/2010 74 Male 159 lb 5/6/2011 Physician Japan
Primary
Concomitant
Ascites Hospitalization 2/7/2011 62 Male 5/9/2011 Physician Japan
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 10/21/2010 31 Male 5/9/2011 Pharmacist Japan
Primary
Concomitant
Lymphocyte Count Decreased Death 1/31/2011 73 Male 5/19/2011 Physician Japan
Primary
Concomitant
Blood Glucose Increased Other Serious 6/4/2010 74 Male 159 lb 5/20/2011 Other Health Professional Japan
Primary
Concomitant
Stomatitis Hospitalization 10/21/2010 31 Male 5/20/2011 Pharmacist Japan
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 9/16/2010 75 Male 119 lb 5/24/2011 Physician Japan
Primary
Concomitant
Palpitations Hospitalization 8/1/2010 60 Male 152 lb 5/25/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Other Serious 12/8/2010 73 Male 176 lb 5/26/2011 Physician Japan
Primary
Concomitant
Lymphocyte Count Decreased Other Serious 7/5/2010 63 Female 126 lb 5/26/2011 Physician Japan
Primary
Concomitant
Rash Other Serious 6/4/2010 74 Male 159 lb 5/27/2011 Other Health Professional Japan
Primary
Concomitant
Stomatitis Other Serious 10/29/2010 79 Male 5/31/2011 Physician Japan
Primary
Concomitant
Blood Amylase Increased Other Serious 10/13/2010 55 Male 170 lb 6/2/2011 Physician Japan
Primary
Concomitant
Neoplasm Malignant Hospitalization 8/9/2010 63 Female 5/31/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Eruption Other Serious 1/27/2011 72 Female 123 lb 6/6/2011 Physician Japan
Primary
Secondary
Concomitant

Drug Data