Blinded *Placebo combined with Sunitinib Malate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Rhinorrhoea Hospitalization 10/23/2009 65 Male 198 lb 11/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 10/23/2009 65 Male 198 lb 11/20/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 Male 3/12/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Chest Pain Hospitalization 3/8/2010 Male 213 lb 3/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Anal Fistula Hospitalization 4/14/2010 66 Male 4/27/2010 Physician United Kingdom
Primary
Secondary
Oral Fungal Infection Hospitalization 3/23/2010 65 Male 5/3/2010 Other Health Professional Denmark
Primary
Secondary
Concomitant
Nervous System Disorder Hospitalization 4/21/2010 76 Male 187 lb 5/3/2010 Physician Germany
Primary
Secondary
Concomitant
Anal Fistula Hospitalization 4/14/2010 66 Male 6/4/2010 Physician United Kingdom
Primary
Secondary
Stomatitis Other Serious 5/6/2010 61 Female 142 lb 6/4/2010 Other Health Professional United States
Primary
Secondary
Anal Abscess Hospitalization 12/27/2009 62 Male 6/8/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Life Threatening 5/15/2010 72 Male 234 lb 6/8/2010 Other Health Professional Denmark
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 3/21/2010 81 Male 142 lb 6/8/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Diverticular Perforation Other Serious 5/16/2010 78 Male 202 lb 6/8/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cellulitis Hospitalization 5/7/2010 47 Male 216 lb 6/9/2010 Physician United States
Primary
Secondary
Cholecystitis Acute Hospitalization 5/31/2010 76 Male 6/10/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Proctitis Other Serious 5/13/2010 65 Male 148 lb 6/11/2010 Physician Peru
Primary
Secondary
Concomitant
General Physical Health Deterioration Death 5/20/2010 77 Male 6/14/2010 Physician France
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 5/4/2010 76 Male 169 lb 6/15/2010 Physician United Kingdom
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 12/12/2008 67 Female 150 lb 6/15/2010 Physician Belgium
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Life Threatening 5/15/2010 72 Male 234 lb 6/16/2010 Other Health Professional Denmark
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 1/27/2010 64 Male 143 lb 6/16/2010 Physician United States
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 3/10/2010 65 Male 187 lb 6/18/2010 Physician Germany
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 10/12/2009 50 Male 170 lb 6/18/2010 Physician United States
Primary
Secondary
Circulatory Collapse Hospitalization 5/3/2010 67 Male 6/21/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/7/2010 70 Male 153 lb 6/21/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Hospitalization 4/15/2010 59 Male 115 lb 6/23/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 5/20/2010 79 Male 172 lb 6/24/2010 Other Health Professional Brazil
Primary
Secondary
Concomitant
Necrosis Other Serious 6/14/2010 71 Male 163 lb 6/24/2010 Physician Germany
Primary
Secondary
Concomitant
Performance Status Decreased Hospitalization 9/30/2008 72 Female 150 lb 6/25/2010 Germany
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 6/20/2010 74 Male 6/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Anal Abscess Hospitalization 2/1/2010 66 Male 6/29/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/13/2010 76 Male 171 lb 6/29/2010 Physician United States
Primary
Secondary
Concomitant
Cellulitis Hospitalization 6/8/2010 59 Male 128 lb 6/29/2010 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Sepsis Life Threatening 10/12/2008 72 Male 162 lb 6/29/2010 Other Health Professional Canada
Primary
Secondary
Acute Myocardial Infarction Life Threatening 8/22/2009 73 Male 141 lb 6/29/2010 Physician Israel
Primary
Secondary
Concomitant
Anal Fistula Hospitalization 4/14/2010 66 Male 6/29/2010 Physician United Kingdom
Primary
Secondary
Cholecystitis Acute Hospitalization 5/31/2010 76 Male 6/29/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 6/3/2009 63 Male 203 lb 6/30/2010 Other Health Professional United States
Primary
Secondary
Transient Ischaemic Attack Hospitalization 11/26/2009 84 Male 196 lb 7/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 7/24/2008 72 Male 198 lb 7/1/2010 Germany
Primary
Secondary
Concomitant
Anaemia Hospitalization 2/17/2010 53 Male 201 lb 7/1/2010 Physician Belgium
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 12/12/2008 67 Female 150 lb 7/2/2010 Physician Belgium
Primary
Secondary
Concomitant
Performance Status Decreased Hospitalization 6/18/2010 69 Male 192 lb 7/2/2010 Physician Germany
Primary
Secondary
Circulatory Collapse Hospitalization 6/23/2010 58 Male 12 lb 7/7/2010 Physician Ireland
Primary
Secondary
Concomitant
Optic Ischaemic Neuropathy Hospitalization 6/24/2010 64 Male 201 lb 7/7/2010 Physician Germany
Primary
Secondary
Concomitant
Cholecystitis Hospitalization 5/6/2010 60 Male 157 lb 7/8/2010 Physician United States
Primary
Secondary
Pneumonia Hospitalization 6/7/2010 70 Male 153 lb 7/8/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/13/2010 76 Male 171 lb 7/8/2010 Physician United States
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 Male 7/9/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Acute Myocardial Infarction Life Threatening 8/22/2009 73 Male 141 lb 7/9/2010 Physician Israel
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 3/10/2010 65 Male 187 lb 7/9/2010 Physician Germany
Primary
Secondary
Concomitant
Peptic Ulcer Hospitalization 4/17/2010 72 Male 139 lb 7/9/2010 Physician Israel
Primary
Secondary
Concomitant
Muscular Weakness Hospitalization 6/14/2010 68 Male 156 lb 7/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Sudden Death Death 54 Female 7/13/2010 Physician United States
Primary
Secondary
Herpes Zoster Hospitalization 6/26/2010 75 Male 117 lb 7/13/2010 Physician Taiwan, Province Of China
Primary
Secondary
Muscular Weakness Hospitalization 4/16/2010 68 Male 159 lb 7/14/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cholecystitis Acute Hospitalization 5/31/2010 76 Male 7/14/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/26/2009 84 Male 196 lb 7/14/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 6/20/2010 74 Male 139 lb 7/14/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Circulatory Collapse Hospitalization 6/23/2010 58 Male 123 lb 7/15/2010 Physician Ireland
Primary
Secondary
Concomitant
Electrocardiogram Abnormal Hospitalization 7/6/2010 46 Female 112 lb 7/19/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Conjunctival Oedema Other Serious 12/2/2009 75 Male 163 lb 7/21/2010 Other Health Professional United Kingdom
Primary
Secondary
Tremor Other Serious 3/15/2010 54 Female 284 lb 7/22/2010 Physician United States
Primary
Secondary
Urinary Tract Infection Life Threatening 3/2/2010 82 Female 138 lb 7/22/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Hyperkalaemia Hospitalization 6/4/2010 64 Female 249 lb 7/23/2010 Other Health Professional United States
Primary
Secondary
Optic Ischaemic Neuropathy Hospitalization 6/24/2010 63 Male 201 lb 7/26/2010 Physician Germany
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 4/22/2010 68 Male 271 lb 7/26/2010 Physician United States
Primary
Secondary
Enterocolitis Infectious Other Serious 11/18/2009 51 Male 251 lb 7/26/2010 Physician United States
Primary
Secondary
Concomitant
Cellulitis Other Serious 12/20/2009 53 Female 285 lb 7/26/2010 Physician United States
Primary
Secondary
Intestinal Haemorrhage Hospitalization 6/10/2010 74 Male 183 lb 7/27/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Diverticulitis Other Serious 5/16/2010 78 Male 202 lb 7/28/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Presyncope Hospitalization 6/23/2010 58 Male 269 lb 7/28/2010 Physician Ireland
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 10/22/2009 70 Male 7/28/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 6/26/2010 75 Male 117 lb 7/30/2010 Physician Taiwan, Province Of China
Primary
Secondary
Drug Toxicity Hospitalization 5/2/2009 68 Male 8/2/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Anal Ulcer Hospitalization 7/20/2010 63 Male 8/3/2010 Physician Germany
Primary
Secondary
Concomitant
Cellulitis Hospitalization 7/23/2010 59 Male 128 lb 8/5/2010 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 12/31/2009 52 Male 218 lb 8/6/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Performance Status Decreased Hospitalization 6/18/2010 69 Male 192 lb 8/9/2010 Physician Germany
Primary
Secondary
Concomitant
Optic Ischaemic Neuropathy Hospitalization 6/24/2010 63 Male 201 lb 8/10/2010 Physician Germany
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/26/2009 84 Male 196 lb 8/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 6/20/2010 66 Female 140 lb 8/12/2010 Other Health Professional United States
Primary
Secondary
Death Death 8/2/2010 53 Male 187 lb 8/13/2010 Physician Poland
Primary
Secondary
Concomitant
Performance Status Decreased Hospitalization 9/30/2008 72 Female 150 lb 8/16/2010 Physician Germany
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/23/2010 59 Male 128 lb 8/17/2010 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Optic Ischaemic Neuropathy Hospitalization 6/24/2010 63 Male 201 lb 8/18/2010 Physician Germany
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 9/28/2008 75 Male 173 lb 8/18/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Troponin Increased Hospitalization 3/11/2009 61 Male 8/19/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Syncope Hospitalization 8/8/2010 75 Male 8/20/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Death Death 12/2/2009 84 Male 196 lb 8/20/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Death Death 8/2/2010 53 Male 187 lb 8/23/2010 Physician Poland
Primary
Secondary
Concomitant
Performance Status Decreased Hospitalization 6/18/2010 69 Male 192 lb 8/25/2010 Physician Germany
Primary
Secondary
Concomitant
Anal Haemorrhage Hospitalization 4/14/2010 66 Male 8/26/2010 Physician United Kingdom
Primary
Secondary
Syncope Hospitalization 8/8/2010 75 Male 8/27/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 2/1/2010 66 Male 8/27/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Necrosis Other Serious 6/14/2010 71 Male 163 lb 8/31/2010 Physician Germany
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 12/31/2009 52 Male 218 lb 8/31/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Diverticulitis Other Serious 5/16/2010 78 Male 202 lb 8/31/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Hospitalization 8/18/2010 62 Male 171 lb 8/31/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/18/2010 63 Male 9/2/2010 Physician United States
Primary
Secondary
Concomitant
Anal Ulcer Hospitalization 7/20/2010 63 Male 9/2/2010 Physician Germany
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 8/2/2010 58 Male 273 lb 9/2/2010 Physician United States
Primary
Secondary
Muscular Weakness Hospitalization 7/10/2010 57 Female 209 lb 9/3/2010 Other Health Professional United States
Primary
Secondary
Presyncope Hospitalization 6/23/2010 58 Male 269 lb 9/6/2010 Physician Ireland
Primary
Secondary
Concomitant
Optic Ischaemic Neuropathy Hospitalization 6/24/2010 63 Male 201 lb 9/7/2010 Physician Germany
Primary
Secondary
Concomitant
Vomiting Hospitalization 6/18/2010 42 Male 186 lb 9/7/2010 Physician United States
Primary
Secondary
Peripheral Sensory Neuropathy Other Serious 1/27/2010 53 Female 190 lb 9/7/2010 Physician United States
Primary
Secondary
Pneumonia Hospitalization 4/22/2010 68 Male 271 lb 9/8/2010 Physician United States
Primary
Secondary
Myocardial Infarction Other Serious 7/20/2010 52 Male 181 lb 9/10/2010 Physician Czech Republic
Primary
Secondary
Concomitant
Small Intestinal Obstruction Hospitalization 8/29/2010 59 Female 110 lb 9/13/2010 Canada
Primary
Secondary
Concomitant
Renal Failure Other Serious 9/3/2010 61 Male 9/15/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Anal Ulcer Hospitalization 7/20/2010 63 Male 9/17/2010 Physician Germany
Primary
Secondary
Concomitant
Axonal Neuropathy Disability 11/13/2009 53 Male 214 lb 9/20/2010 Physician France
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 7/20/2010 52 Male 181 lb 9/21/2010 Physician Czech Republic
Primary
Secondary
Transient Ischaemic Attack Hospitalization 11/26/2009 84 Male 196 lb 9/21/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Hospitalization 8/18/2010 62 Male 171 lb 9/22/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 6/18/2010 42 Male 186 lb 9/27/2010 Physician United States
Primary
Secondary
Renal Failure Other Serious 9/3/2010 61 Male 9/27/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/7/2010 70 Male 9/28/2010 Physician United Kingdom
Primary
Secondary
Renal Failure Acute Life Threatening 12/31/2009 52 Male 218 lb 9/29/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 10/24/2009 77 Male 385 lb 10/4/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 6/28/2010 54 Female 111 lb 10/5/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Other Serious 2/9/2010 65 Female 119 lb 10/6/2010 Physician Germany
Primary
Secondary
Intestinal Haemorrhage Hospitalization 6/10/2010 74 Male 183 lb 10/6/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Chest Pain Hospitalization 9/21/2010 85 Male 108 lb 10/6/2010 Physician Taiwan, Province Of China
Primary
Secondary
Vomiting Hospitalization 9/25/2010 53 Male 10/7/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Sepsis Other Serious 6/1/2010 70 Male 153 lb 10/12/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Death Death 10/5/2010 79 Male 175 lb 10/12/2010 Brazil
Primary
Secondary
Hydropneumothorax Other Serious 9/28/2010 66 Male 150 lb 10/13/2010 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Phlebitis Hospitalization 10/3/2010 59 Male 172 lb 10/14/2010 Physician France
Primary
Secondary
Concomitant
Syncope Hospitalization 8/8/2010 75 Male 10/14/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pneumonitis Other Serious 10/15/2010 Physician Denmark
Primary
Secondary
Pneumonia Hospitalization 8/18/2010 63 Male 10/18/2010 Physician United States
Primary
Secondary
Concomitant
Oesophagitis Hospitalization 3/25/2009 72 Male 159 lb 10/18/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Diverticulitis Other Serious 5/16/2010 68 Male 202 lb 10/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/7/2010 70 Male 10/20/2010 Physician United Kingdom
Primary
Secondary
Cerebrovascular Accident Hospitalization 10/8/2010 54 Male 176 lb 10/21/2010 Physician Sweden
Primary
Secondary
Urinary Tract Infection Hospitalization 10/24/2009 77 Male 385 lb 10/19/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Speech Disorder Hospitalization 9/22/2009 81 Male 146 lb 10/25/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Multi-organ Failure Death 10/9/2010 Male 194 lb 10/25/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Post Herpetic Neuralgia Hospitalization 9/21/2010 85 Male 108 lb 10/25/2010 Physician Taiwan, Province Of China
Primary
Secondary
Vena Cava Thrombosis Hospitalization 9/27/2010 53 Male 10/25/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 10/8/2010 54 Male 176 lb 10/26/2010 Physician Sweden
Primary
Secondary
Peripheral Sensory Neuropathy Other Serious 12/21/2008 61 Male 209 lb 10/28/2010 Physician United States
Primary
Secondary
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 3/30/2010 20 Female 117 lb 10/28/2010 Other Health Professional United States
Primary
Secondary
White Blood Cell Count Decreased Death 10/9/2010 66 Male 194 lb 11/2/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Dizziness Hospitalization 6/8/2010 59 Male 128 lb 11/2/2010 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Dermatitis Acneiform Other Serious 2/11/2010 52 Male 254 lb 11/2/2010 Physician United States
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Hospitalization 4/15/2010 59 Male 115 lb 11/2/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/23/2010 59 Male 128 lb 11/3/2010 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant

Drug Data