Blinded *Placebo combined with Blinded Sunitinib Malate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Vomiting Hospitalization 11/2/2008 12/11/2008 Physician Hungary
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/2/2008 12/12/2008 Physician Hungary
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 10/20/2008 12/15/2008 Physician Canada
Primary
Secondary
Sepsis Hospitalization 11/16/2008 12/15/2008 Physician Brazil
Primary
Secondary
Concomitant
Vomiting Other Serious 5/23/2008 73 Male 196 lb 12/15/2008 Physician United States
Primary
Secondary
Rectal Haemorrhage Hospitalization 11/27/2008 Female 125 lb 12/17/2008 Other Health Professional United States
Primary
Secondary
Weight Decreased Hospitalization 10/3/2008 12/19/2008 Physician Norway
Primary
Secondary
Concomitant
Cellulitis Other Serious 10/17/2008 58 Male 238 lb 12/19/2008 Other Health Professional
Primary
Secondary
Asphyxia Hospitalization 11/29/2008 12/19/2008 Physician Russian Federation
Primary
Secondary
Anal Abscess Hospitalization 12/8/2008 12/19/2008 Other Health Professional Australia
Primary
Secondary
Intestinal Obstruction Hospitalization 9/26/2008 12/19/2008 Physician Cyprus
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Hospitalization 6/4/2008 12/19/2008 Other Health Professional Ukraine
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 12/10/2008 12/19/2008 Other Health Professional Poland
Primary
Secondary
Concomitant
Respiratory Failure Death 7/24/2008 12/22/2008 Germany
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 9/28/2008 Male 173 lb 12/23/2008 Physician United States
Primary
Secondary
Concomitant
Nodal Arrhythmia Hospitalization 10/14/2008 65 Male 212 lb 12/24/2008 Other Health Professional
Primary
Secondary
Concomitant
Syncope Other Serious 39 Female 130 lb 12/24/2008 Other Health Professional
Primary
Secondary
Peripheral Sensory Neuropathy Other Serious 4/17/2008 60 Female 225 lb 12/24/2008 Other Health Professional United States
Primary
Secondary
Dermatitis Acneiform Other Serious 2/11/2008 48 Male 234 lb 12/24/2008 Other Health Professional United States
Primary
Secondary
General Physical Health Deterioration Hospitalization 12/12/2008 12/24/2008 Physician Belgium
Primary
Secondary
Concomitant
Death Death 12/16/2008 12/29/2008 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/10/2008 12/31/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Ileus Hospitalization 12/17/2008 12/31/2008 Germany
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 12/12/2008 1/2/2009 Physician Belgium
Primary
Secondary
Concomitant
Non-small Cell Lung Cancer Hospitalization 8/19/2008 1/5/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Cerebrovascular Accident Death 11/25/2008 1/2/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/10/2008 1/8/2009 Physician India
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 12/9/2008 1/9/2009 Physician Hungary
Primary
Secondary
Concomitant
Peripheral Sensory Neuropathy Other Serious 5/17/2008 54 Male 211 lb 1/9/2009 Other Health Professional United States
Primary
Secondary
Blood Creatinine Increased Hospitalization 12/29/2008 1/9/2009 Physician Singapore
Primary
Secondary
Concomitant
Pyrexia Other Serious 11/25/2008 30 Female 196 lb 1/9/2009 Other Health Professional United States
Primary
Secondary
Hypomagnesaemia Hospitalization 12/30/2008 Female 135 lb 1/9/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Memory Impairment Other Serious 1/9/2009 Other Health Professional United Kingdom
Primary
Secondary
Thrombocytopenia Life Threatening 10/23/2008 1/12/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Non-small Cell Lung Cancer Hospitalization 8/19/2008 1/14/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Intestinal Ischaemia Other Serious 11/25/2008 Male 195 lb 1/14/2009 Physician United States
Primary
Secondary
Concomitant
Amnesia Other Serious 11/27/2008 1/14/2009 Other Health Professional United Kingdom
Primary
Secondary
Urinary Tract Infection Hospitalization 1/2/2009 1/15/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 12/22/2008 1/16/2009 Physician South Africa
Primary
Secondary
Lung Infection Hospitalization 12/4/2008 1/15/2009 Other Health Professional Denmark
Primary
Secondary
Concomitant
Cerebrovascular Accident Death 11/25/2008 1/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/9/2008 Male 93 lb 1/19/2009 Physician Hungary
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 7/9/2008 78 Female 200 lb 1/19/2009 Physician United States
Primary
Secondary
Tremor Hospitalization 1/8/2009 1/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Jugular Vein Thrombosis Hospitalization 12/16/2008 1/21/2009 Physician Brazil
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 12/30/2008 Female 135 lb 1/21/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 11/21/2008 1/22/2009 Other Health Professional Belgium
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 12/22/2008 1/23/2009 Physician South Africa
Primary
Secondary
Gastrointestinal Pain Hospitalization 12/28/2008 1/26/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Peritonitis Hospitalization 1/1/2009 1/28/2009 Physician Russian Federation
Primary
Secondary
Concomitant
Amnesia Other Serious 11/28/2008 1/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Cerebrovascular Accident Death 11/25/2008 Male 1/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Non-small Cell Lung Cancer Hospitalization 12/9/2008 1/28/2009 Physician Hungary
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 10/23/2008 1/29/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 11/19/2008 1/30/2009 Physician Austria
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 12/30/2008 1/30/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Ileus Hospitalization 1/20/2009 2/2/2009 Physician Sweden
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 12/10/2008 2/3/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 12/22/2008 2/3/2009 Physician South Africa
Primary
Secondary
Loss Of Consciousness Life Threatening 1/26/2009 2/5/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 12/8/2008 2/6/2009 Other Health Professional Australia
Primary
Secondary
Erythema Multiforme Hospitalization 11/6/2008 2/6/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 1/17/2009 Female 86 lb 2/9/2009 Physician United States
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 9/28/2008 Male 173 lb 2/9/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 12/2/2008 2/10/2009 Physician France
Primary
Secondary
Urinary Tract Infection Hospitalization 1/28/2009 2/10/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Cognitive Disorder Other Serious 8/31/2007 23 Female 134 lb 2/11/2009 Other Health Professional United States
Primary
Secondary
Asphyxia Hospitalization 11/29/2008 2/11/2009 Physician Russian Federation
Primary
Secondary
Ascites Other Serious 2/11/2009 Physician United Kingdom
Primary
Secondary
Platelet Disorder Other Serious 6/18/2007 67 Female 209 lb 2/11/2009 Other Health Professional United States
Primary
Secondary
Urinary Tract Infection Hospitalization 1/2/2009 2/11/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Sepsis Life Threatening 10/12/2008 2/11/2009 Other Health Professional Canada
Primary
Secondary
Peripheral Sensory Neuropathy Other Serious 9/28/2007 2/11/2009 Physician Canada
Primary
Secondary
Concomitant
Pseudomembranous Colitis Hospitalization 2/3/2009 2/13/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 2/3/2009 2/13/2009 Other Health Professional South Africa
Primary
Secondary
Intestinal Ischaemia Other Serious 11/25/2008 Male 195 lb 2/13/2009 Physician United States
Primary
Secondary
Concomitant
Superinfection Life Threatening 12/29/2008 2/16/2009 Physician Spain
Primary
Secondary
Concomitant
Vomiting Hospitalization 12/15/2008 2/18/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Lung Infection Hospitalization 12/4/2008 2/18/2009 Other Health Professional Denmark
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 1/8/2009 2/18/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Sepsis Hospitalization 7/15/2008 2/18/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/10/2008 2/19/2009 Physician India
Primary
Secondary
Concomitant
Sepsis Hospitalization 11/16/2008 2/20/2009 Physician Brazil
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 1/26/2009 2/20/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/28/2009 2/23/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 1/7/2008 Male 200 lb 2/24/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 1/17/2009 Female 86 lb 2/24/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Ileus Hospitalization 1/20/2009 2/25/2009 Physician Sweden
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 2/11/2009 2/25/2009 Other Health Professional United Kingdom
Primary
Secondary
Ascites Hospitalization 1/27/2009 2/26/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Blood Creatinine Increased Hospitalization 12/29/2008 2/27/2009 Physician Singapore
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/2/2009 2/27/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Renal Failure Hospitalization 2/5/2009 2/27/2009 Other Health Professional Germany
Primary
Secondary
Urosepsis Hospitalization 2/13/2009 2/27/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 2/17/2009 3/3/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 2/11/2009 3/4/2009 Other Health Professional United Kingdom
Primary
Secondary
Peripheral Sensory Neuropathy Other Serious 1/22/2007 53 Male 284 lb 3/4/2009 Physician United States
Primary
Secondary
Death Death 2/19/2008 3/4/2009 Physician Poland
Primary
Secondary
Concomitant
Sepsis Hospitalization 7/15/2008 3/4/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/16/2009 37 Male 222 lb 3/4/2009 Other Health Professional
Primary
Secondary
Sepsis Hospitalization 7/15/2008 3/6/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Vomiting Other Serious 5/23/2008 73 Male 196 lb 3/6/2009 Physician United States
Primary
Secondary
Death Death 1/29/2009 3/9/2009 Physician Poland
Primary
Secondary
Concomitant
Diverticulitis Hospitalization 2/13/2009 Female 123 lb 3/9/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Hyponatraemia Other Serious 2/24/2009 3/9/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Ileus Hospitalization 1/23/2009 Female 190 lb 3/9/2009 Other Health Professional United States
Primary
Secondary
Pulmonary Embolism Hospitalization 8/26/2008 3/9/2009 Germany
Primary
Secondary
Concomitant
Hypotension Hospitalization 2/20/2009 3/9/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Acute Myocardial Infarction Hospitalization 2/22/2008 3/9/2009 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Nausea Hospitalization 2/25/2009 3/10/2009 Physician Sweden
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 12/22/2008 3/12/2009 Physician South Africa
Primary
Secondary
Anal Abscess Hospitalization 12/8/2008 3/12/2009 Other Health Professional Australia
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 2/17/2009 3/12/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Bundle Branch Block Left Hospitalization 2/26/2009 3/13/2009 Physician Italy
Primary
Secondary
Pleural Effusion Hospitalization 5/24/2008 3/13/2009 Other Health Professional Canada
Primary
Secondary
Small Cell Lung Cancer Metastatic Death 12/16/2008 3/16/2009 Physician Hungary
Primary
Secondary
General Physical Health Deterioration Hospitalization 3/3/2009 3/16/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Intestinal Ischaemia Other Serious 11/25/2008 Male 195 lb 3/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 2/5/2009 3/17/2009 Other Health Professional Germany
Primary
Secondary
Hypoglycaemia Hospitalization 3/5/2009 3/18/2009 Physician Sweden
Primary
Secondary
Concomitant
Nausea Hospitalization 2/25/2009 3/18/2009 Physician Sweden
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 3/5/2009 Male 141 lb 3/19/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pupils Unequal Hospitalization 2/27/2009 3/18/2009 Other Health Professional Spain
Primary
Secondary
Pupils Unequal Hospitalization 2/27/2009 3/25/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Vomiting Hospitalization 2/5/2009 3/23/2009 Physician Sweden
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 12/16/2008 Male 197 lb 3/25/2009 United States
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 3/5/2009 3/26/2009 Physician Sweden
Primary
Secondary
Concomitant
Pneumonia Hospitalization 2/23/2009 3/23/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 11/12/2008 3/24/2009 Physician Austria
Primary
Secondary
Concomitant
Pyrexia Hospitalization 1/13/2009 3/23/2009 Physician Singapore
Primary
Secondary
Concomitant
Lung Infection Hospitalization 12/4/2008 3/25/2009 Other Health Professional Denmark
Primary
Secondary
Concomitant
Haematuria Hospitalization 3/17/2009 3/27/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Ischaemic Stroke Hospitalization 2/17/2009 3/27/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Metastases To Meninges Hospitalization 3/3/2009 3/30/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Colonic Obstruction Death 9/1/2008 3/30/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Intestinal Ischaemia Other Serious 11/25/2008 Male 195 lb 3/30/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Hyponatraemia Other Serious 2/24/2009 3/31/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Sinus Tachycardia Hospitalization 1/7/2009 Male 200 lb 3/31/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 2/23/2009 3/31/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Urticaria Other Serious 1/23/2009 4/3/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Hydronephrosis Hospitalization 3/4/2009 4/3/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Peripheral Sensory Neuropathy Other Serious 10/7/2008 57 Male 159 lb 4/3/2009 Other Health Professional United States
Primary
Secondary
Renal Failure Acute Other Serious 2/11/2009 4/6/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pericardial Effusion Hospitalization 2/10/2009 4/6/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 2/18/2009 4/6/2009 Physician Sweden
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/24/2009 4/7/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 3/23/2009 4/7/2009 Physician Netherlands
Primary
Secondary
Vomiting Hospitalization 2/5/2009 4/7/2009 Physician Sweden
Primary
Secondary
Concomitant
Stomatitis Life Threatening 3/19/2009 4/8/2009 Physician Romania
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 3/18/2009 Male 173 lb 4/8/2009 Other Health Professional United States
Primary
Secondary
Concomitant

Drug Data