Blinded *NO Subject Drug combined with Blinded Sunitinib Malate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Vaginal Haemorrhage Other Serious 6/5/2008 41 Female 132 lb 6/25/2009 United States
Primary
Secondary
Chest Pain Hospitalization 3/30/2009 58 6/26/2009 Physician Canada
Primary
Secondary
Pleural Effusion Hospitalization 3/23/2009 66 6/26/2009 Physician Netherlands
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/3/2009 68 6/29/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 1/17/2009 Female 86 lb 6/30/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Lethargy Hospitalization 5/7/2009 7/2/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Memory Impairment Other Serious 5/21/2009 51 Male 171 lb 7/3/2009 Other Health Professional
Primary
Secondary
Malaise Hospitalization 5/3/2009 57 7/6/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 10/3/2008 48 7/7/2009 Physician Norway
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 80 7/8/2009 Physician Spain
Primary
Secondary
Concomitant
Performance Status Decreased Hospitalization 9/30/2008 72 7/8/2009 Germany
Primary
Secondary
Concomitant
Agitated Depression Hospitalization 5/18/2009 59 7/8/2009 Physician Germany
Primary
Secondary
Death Death 6/12/2009 80 7/8/2009 Physician Spain
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/2/2008 58 7/13/2009 Physician Hungary
Primary
Secondary
Concomitant
Thrombosis Other Serious 4/2/2009 71 Male 167 lb 7/14/2009 Other Health Professional United States
Primary
Secondary
General Physical Health Deterioration Hospitalization 3/19/2009 69 7/14/2009 Physician France
Primary
Secondary
Pericardial Effusion Hospitalization 2/10/2009 59 7/15/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 3/22/2009 Male 161 lb 7/16/2009 United States
Primary
Secondary
Concomitant
Dehydration Death 9/23/2008 79 7/16/2009 Other Health Professional Belgium
Primary
Secondary
Concomitant
Peripheral Vascular Disorder Life Threatening 11/25/2008 59 7/16/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Respiratory Failure Death 7/24/2008 72 7/17/2009 Physician Germany
Primary
Secondary
Concomitant
Vertigo Hospitalization 6/24/2009 68 7/20/2009 Physician Israel
Primary
Secondary
Concomitant
Death Death 6/12/2009 80 7/20/2009 Physician Spain
Primary
Secondary
Concomitant
Lung Abscess Hospitalization 10/14/2008 62 7/20/2009 Physician Singapore
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 80 7/20/2009 Physician Spain
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 11/12/2008 65 7/21/2009 Physician Austria
Primary
Secondary
Concomitant
Death Death 8/7/2008 28 7/21/2009 Physician India
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 9/28/2008 Male 173 lb 7/21/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Oral Pain Hospitalization 12/28/2008 60 7/22/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Agitated Depression Hospitalization 5/18/2009 59 7/24/2009 Germany
Primary
Secondary
Small Intestinal Obstruction Life Threatening 4/17/2009 75 7/24/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Facial Palsy Hospitalization 7/6/2009 81 7/28/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 1/26/2009 33 7/28/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Renal Failure Hospitalization 3/17/2008 56 7/29/2009 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 2/3/2009 70 7/31/2009 Other Health Professional South Africa
Primary
Secondary
Subcutaneous Abscess Hospitalization 12/22/2008 70 7/31/2009 Physician South Africa
Primary
Secondary
Subcutaneous Abscess Hospitalization 12/22/2008 70 7/31/2009 Physician South Africa
Primary
Secondary
Agitated Depression Hospitalization 5/18/2009 59 8/4/2009 Germany
Primary
Secondary
Subcutaneous Abscess Hospitalization 7/6/2009 81 8/4/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 7/23/2009 68 8/4/2009 Physician France
Primary
Secondary
Concomitant
Syncope Hospitalization 5/30/2009 8/12/2009 Other Health Professional Canada
Primary
Secondary
Psychotic Disorder Other Serious 5/15/2009 53 Male 274 lb 8/14/2009 Other Health Professional United States
Primary
Secondary
Subcutaneous Abscess Hospitalization 7/6/2009 81 8/21/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 8/13/2009 Male 275 lb 8/27/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Intestinal Ischaemia Other Serious 11/25/2008 Male 195 lb 8/31/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Performance Status Decreased Hospitalization 8/14/2009 65 9/1/2009 Other Health Professional Belgium
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 12/15/2008 63 9/1/2009 Other Health Professional Canada
Primary
Secondary
Death Death 12/18/2008 51 9/1/2009 Physician Poland
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 8/8/2009 54 9/1/2009 Physician Poland
Primary
Secondary
Concomitant
Sudden Cardiac Death Death 5/19/2009 66 9/2/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 8/22/2009 73 9/4/2009 Physician Israel
Primary
Secondary
Agitated Depression Hospitalization 5/18/2009 59 9/3/2009 Germany
Primary
Secondary
Asphyxia Hospitalization 11/29/2008 42 9/7/2009 Physician Russian Federation
Primary
Secondary
Respiratory Failure Hospitalization 8/14/2009 66 9/8/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Peripheral Sensory Neuropathy Other Serious 5/11/2009 54 Male 177 lb 9/4/2009 Other Health Professional United States
Primary
Secondary
Diarrhoea Hospitalization 6/22/2008 72 9/10/2009 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Hypercalcaemia Life Threatening 3/19/2009 71 9/11/2009 Physician Romania
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 7/14/2009 72 9/15/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Superinfection Life Threatening 12/29/2008 57 9/16/2009 Physician Spain
Primary
Secondary
Concomitant
Hypertension Hospitalization 4/30/2009 62 9/17/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Vomiting Hospitalization 2/18/2009 71 9/17/2009 Physician Sweden
Primary
Secondary
Concomitant
Liver Function Test Abnormal Hospitalization 7/23/2009 68 9/18/2009 Physician France
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 8/7/2009 69 9/18/2009 Physician Israel
Primary
Secondary
Concomitant
Acute Myocardial Infarction Life Threatening 8/22/2009 73 9/18/2009 Physician Israel
Primary
Secondary
Concomitant
Febrile Infection Hospitalization 4/28/2009 76 9/22/2009 Physician Finland
Primary
Secondary
Concomitant
Sepsis Life Threatening 10/12/2008 72 9/22/2009 Other Health Professional Canada
Primary
Secondary
Hypomagnesaemia Hospitalization 12/30/2008 45 9/23/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Haemorrhage Life Threatening 9/10/2009 43 9/23/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Pneumonia Life Threatening 9/16/2009 69 9/22/2009 Physician Germany
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 7/14/2009 72 9/24/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Pneumonia Life Threatening 9/16/2009 69 9/25/2009 Physician Germany
Primary
Secondary
Concomitant
Hypertension Hospitalization 4/30/2009 62 9/25/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Death Death 11/30/2008 54 9/29/2009 Other Health Professional Czech Republic
Primary
Secondary
Hypophosphataemia Hospitalization 9/15/2009 69 9/28/2009 Physician Israel
Primary
Secondary
Concomitant
Agitated Depression Hospitalization 5/18/2009 59 9/29/2009 Germany
Primary
Secondary
Urinary Tract Infection Pseudomonal Hospitalization 4/8/2009 70 9/29/2009 Physician Greece
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 1/8/2009 73 10/1/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Prostate Cancer Hospitalization 8/14/2009 65 9/30/2009 Other Health Professional Belgium
Primary
Secondary
Concomitant
Chest Pain Hospitalization 3/30/2009 59 Male 168 lb 10/2/2009 Physician Canada
Primary
Secondary
Mental Status Changes Hospitalization 9/22/2009 Male 140 lb 10/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 8/11/2009 65 Female 136 lb 10/6/2009 Physician United States
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 10/21/2008 67 10/7/2009 Physician Poland
Primary
Secondary
Concomitant
Death Death 1/29/2009 67 10/7/2009 Physician Poland
Primary
Secondary
Concomitant
Pneumonia Life Threatening 9/16/2009 69 10/8/2009 Physician Germany
Primary
Secondary
Concomitant
Death Death 12/18/2008 51 10/12/2009 Physician Poland
Primary
Secondary
Concomitant
Hypophosphataemia Hospitalization 9/15/2009 69 10/12/2009 Physician Israel
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 2/11/2009 74 10/14/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 8/7/2009 69 10/13/2009 Physician Israel
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/21/2009 78 10/19/2009 Physician China
Primary
Secondary
Hyponatraemia Hospitalization 9/28/2008 Male 173 lb 10/19/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 9/22/2009 Male 140 lb 10/19/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 12/16/2008 Male 197 lb 10/20/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/21/2009 78 10/21/2009 Physician China
Primary
Secondary
Gastrointestinal Haemorrhage Life Threatening 10/8/2009 53 10/21/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/10/2008 47 10/22/2009 Physician India
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 8/13/2009 Male 275 lb 10/22/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Sudden Cardiac Death Death 5/19/2009 66 10/23/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 10/12/2009 65 10/26/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 7/14/2009 72 10/27/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 3/5/2009 71 10/27/2009 Physician Sweden
Primary
Secondary
Concomitant
Cerebrovascular Accident Other Serious 10/7/2009 69 10/27/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Bundle Branch Block Left Hospitalization 2/26/2009 65 10/27/2009 Other Health Professional Italy
Primary
Secondary
Hypertension Hospitalization 4/30/2009 62 10/27/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 9/28/2008 Male 173 lb 10/28/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Paronychia Hospitalization 3/15/2009 77 10/29/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Polyneuropathy In Malignant Disease Hospitalization 9/21/2009 64 10/29/2009 Physician Israel
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 10/30/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 10/12/2009 65 Male 195 lb 11/2/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Wound Complication Other Serious 9/8/2009 66 Female 230 lb 11/3/2009 Other Health Professional United States
Primary
Secondary
Pain In Extremity Hospitalization 9/7/2009 54 Male 214 lb 11/3/2009 Physician United States
Primary
Secondary
Syncope Hospitalization 7/27/2009 44 Female 207 lb 11/3/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Bone Pain Other Serious 9/6/2009 51 Female 150 lb 11/4/2009 Other Health Professional United States
Primary
Secondary
Vomiting Hospitalization 7/10/2008 53 Female 134 lb 11/4/2009 Other Health Professional Australia
Primary
Secondary
Concomitant
Dehydration Hospitalization 8/10/2009 Male 275 lb 11/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Rhinorrhoea Hospitalization 10/23/2009 65 Male 198 lb 11/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Hospitalization 4/24/2009 47 Male 143 lb 11/5/2009 Physician South Africa
Primary
Secondary
Concomitant
Cerebral Ischaemia Disability 10/28/2009 69 Male 192 lb 11/9/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 9/1/2009 Male 148 lb 11/11/2009 Physician United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 10/8/2009 53 Male 148 lb 11/11/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Confusional State Hospitalization 9/22/2009 Male 140 lb 11/11/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 7/14/2009 72 Male 187 lb 11/12/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/22/2008 52 Male 106 lb 11/12/2009 Physician India
Primary
Secondary
Concomitant
Non-small Cell Lung Cancer Hospitalization 8/19/2008 64 Male 134 lb 11/16/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Intestinal Obstruction Hospitalization 10/31/2009 61 Male 187 lb 11/17/2009 Other Health Professional Belgium
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 10/7/2009 69 Male 204 lb 11/16/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Subcutaneous Haematoma Hospitalization 10/24/2009 Male 182 lb 11/18/2009 Physician United States
Primary
Secondary
Concomitant
Non-small Cell Lung Cancer Hospitalization 8/14/2009 66 Female 110 lb 11/18/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 9/28/2008 Male 173 lb 11/19/2009 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
Rectal Ulcer Hospitalization 7/14/2009 72 Male 187 lb 11/23/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Polyneuropathy In Malignant Disease Hospitalization 9/21/2009 64 Male 216 lb 11/25/2009 Physician Israel
Primary
Secondary
Concomitant
Death Death 8/7/2008 28 Male 134 lb 11/25/2009 Physician India
Primary
Secondary
Concomitant
Renal Impairment Other Serious 7/25/2008 76 Female 128 lb 11/25/2009 Physician Mexico
Primary
Secondary
Concomitant
Death Death 10/24/2009 70 Male 11/25/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/10/2008 47 Male 82 lb 11/25/2009 Physician India
Primary
Secondary
Concomitant
Fall Hospitalization 10/24/2009 Male 182 lb 11/30/2009 Physician United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 11/16/2009 Male 240 lb 11/30/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Histoplasmosis Hospitalization 9/21/2009 52 Female 228 lb 12/2/2009 Other Health Professional United States
Primary
Secondary
Gastroenteritis Hospitalization 9/1/2009 Male 148 lb 12/3/2009 Physician United States
Primary
Secondary
Concomitant
Urinary Bladder Haemorrhage Hospitalization 11/18/2009 61 Male 153 lb 12/3/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Cerebral Ischaemia Disability 10/28/2009 69 Male 192 lb 12/3/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Sepsis Death 11/26/2009 Male 218 lb 12/4/2009 Physician United States
Primary
Secondary
Concomitant
Death Death 12/2/2009 Male 196 lb 12/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Diverticular Perforation Hospitalization 11/25/2009 80 Male 152 lb 12/4/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Peripheral Sensory Neuropathy Other Serious 5/28/2009 40 Male 147 lb 12/10/2009 Physician United States
Primary
Secondary
Drug Toxicity Hospitalization 5/2/2009 68 Male 12/11/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Confusional State Hospitalization 9/22/2009 Male 140 lb 12/11/2009 Other Health Professional United States
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 12/2/2009 69 Male 170 lb 12/14/2009 Physician Italy
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/26/2009 Male 196 lb 12/14/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Death 11/26/2009 Male 218 lb 12/17/2009 Physician United States
Primary
Secondary
Concomitant

Drug Data