Blinded *NO Subject Drug combined with Blinded *Placebo

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Transient Ischaemic Attack Other Serious 2/13/2009 76 6/24/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vaginal Haemorrhage Other Serious 6/5/2008 41 Female 132 lb 6/25/2009 United States
Primary
Secondary
Sudden Death Death 6/17/2009 78 6/26/2009 Physician Hong Kong
Primary
Secondary
Concomitant
Pneumonia Hospitalization 2/20/2006 26 6/26/2009 Physician Poland
Primary
Secondary
Concomitant
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
Cardiac Failure Congestive Hospitalization 3/23/2009 Male 301 lb 6/26/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Hypertensive Crisis Hospitalization 6/12/2009 61 6/26/2009 Physician Philippines
Primary
Secondary
Concomitant
Respiratory Distress Other Serious 1/29/2009 Male 186 lb 6/26/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Lymphoma Hospitalization 3/9/2009 49 6/26/2009 Physician Italy
Primary
Secondary
Concomitant
Iron Deficiency Anaemia Other Serious 3/12/2009 Female 181 lb 6/29/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/3/2009 68 6/29/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 3/23/2009 Female 117 lb 6/29/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Septic Shock Death 3/4/2009 64 6/30/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 1/17/2009 Female 86 lb 6/30/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Insomnia Hospitalization 1/23/2009 13 6/30/2009 Physician Russian Federation
Primary
Secondary
Concomitant
Arthritis Hospitalization 6/22/2009 44 7/2/2009 Physician Ukraine
Primary
Secondary
Lethargy Hospitalization 5/7/2009 7/2/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Musculoskeletal Pain Hospitalization 6/3/2009 61 7/2/2009 Physician Poland
Primary
Secondary
Concomitant
Memory Impairment Other Serious 5/21/2009 51 Male 171 lb 7/3/2009 Other Health Professional
Primary
Secondary
Shock Life Threatening 1/21/2009 30 7/3/2009 Other Health Professional Belgium
Primary
Secondary
Concomitant
Malaise Hospitalization 5/3/2009 57 7/6/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 5/31/2009 Male 260 lb 7/6/2009 United States
Primary
Secondary
Concomitant
Haematoma Other Serious 2/16/2009 Male 239 lb 7/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Right Atrial Dilatation Hospitalization 5/4/2009 Male 262 lb 7/6/2009 Other Health Professional United States
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
Pulmonary Hypertension Hospitalization 8/7/2008 47 7/8/2009 Physician France
Primary
Secondary
Renal Impairment Hospitalization 6/21/2009 74 7/10/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Arthritis Hospitalization 6/22/2009 44 7/10/2009 Physician Ukraine
Primary
Secondary
Vomiting Hospitalization 11/2/2008 58 7/13/2009 Physician Hungary
Primary
Secondary
Concomitant
Cholecystitis Acute Hospitalization 2/18/2009 74 7/10/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Other Serious 9/15/2008 33 7/13/2009 Physician Belgium
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 5/31/2009 Male 260 lb 7/13/2009 Physician United States
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
Trigeminal Neuralgia Other Serious 2/2/2006 58 7/13/2009 Physician Spain
Primary
Secondary
Concomitant
Renal Failure Other Serious 4/16/2009 Male 225 lb 7/15/2009 United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 1/23/2009 Male 146 lb 7/15/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pericardial Effusion Hospitalization 2/10/2009 59 7/15/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Sepsis Life Threatening 1/14/2008 Male 229 lb 7/15/2009 Other Health Professional United States
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
Tongue Neoplasm Malignant Stage Unspecified Other Serious 7/1/2008 Male 161 lb 7/16/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Failure Death 7/24/2008 72 7/17/2009 Physician Germany
Primary
Secondary
Concomitant
Lung Neoplasm Hospitalization 5/16/2005 Male 139 lb 7/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 8/4/2007 Male 7/17/2009 Physician United States
Primary
Secondary
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
Vulval Cancer Other Serious 6/8/2007 29 7/20/2009 Physician Argentina
Primary
Secondary
Concomitant
Prostate Cancer Hospitalization 1/24/2007 66 7/20/2009 Physician Germany
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 80 7/20/2009 Physician Spain
Primary
Secondary
Concomitant
Gout Other Serious 3/21/2009 73 7/21/2009 Other Health Professional Hong Kong
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
Sudden Death Death 6/17/2009 78 7/21/2009 Other Health Professional Hong Kong
Primary
Secondary
Concomitant
Oesophageal Carcinoma Other Serious 8/1/2005 Male 137 lb 7/22/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Oral Pain Hospitalization 12/28/2008 60 7/22/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Syncope Hospitalization 8/25/2008 Male 190 lb 7/23/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Agitated Depression Hospitalization 5/18/2009 59 7/24/2009 Germany
Primary
Secondary
Cardiac Failure Congestive Hospitalization 3/23/2009 Male 301 lb 7/24/2009 Other Health Professional United States
Primary
Secondary
Concomitant
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
Right Ventricular Failure Hospitalization 7/19/2009 Male 7/28/2009 Physician United States
Primary
Secondary
Renal Failure Hospitalization 3/17/2008 56 7/29/2009 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 6/12/2008 73 7/28/2009 Physician Peru
Primary
Secondary
Concomitant
Renal Impairment Other Serious 3/21/2009 57 7/30/2009 Physician Costa Rica
Primary
Secondary
Concomitant
Renal Failure Other Serious 4/16/2009 Male 218 lb 7/30/2009 United States
Primary
Secondary
Concomitant
Myocardial Ischaemia Hospitalization 8/10/2008 Male 223 lb 7/27/2009 Physician United States
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
Renal Impairment Other Serious 3/21/2009 57 8/3/2009 Physician Costa Rica
Primary
Secondary
Concomitant
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
Pyelonephritis Acute Hospitalization 10/8/2008 49 8/4/2009 Physician Germany
Primary
Secondary
Concomitant
Vision Blurred Hospitalization 2/27/2009 Female 245 lb 8/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Death Hospitalization 3/21/2009 60 8/6/2009 Physician France
Primary
Secondary
Concomitant
Heart Rate Irregular Hospitalization 1/13/2007 Female 165 lb 8/10/2009 Other Health Professional United States
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
Pulmonary Hypertension Hospitalization 5/12/2009 57 8/14/2009 Brazil
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 4/1/2008 64 8/14/2009 Physician Philippines
Primary
Secondary
Concomitant
Syncope Hospitalization 8/25/2008 Male 190 lb 8/14/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 4/16/2009 Male 218 lb 8/17/2009 United States
Primary
Secondary
Concomitant
Oesophageal Spasm Hospitalization 7/24/2009 63 8/17/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 12/25/2008 59 Male 8/21/2009 Physician United States
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 7/6/2009 81 8/21/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization 5/8/2007 Female 212 lb 8/21/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Cholecystitis Disability 8/7/2009 71 8/24/2009 Physician United Kingdom
Primary
Secondary
Myocardial Infarction Hospitalization 12/23/2008 80 8/25/2009 Physician Germany
Primary
Secondary
Concomitant
Rectal Cancer Other Serious 12/18/2006 59 8/26/2009 Physician Belgium
Primary
Secondary
Febrile Neutropenia Life Threatening 4/19/2009 31 8/26/2009 Physician Belgium
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 8/13/2009 Male 275 lb 8/27/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 4/1/2008 64 8/28/2009 Physician Philippines
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 8/25/2008 Male 190 lb 8/28/2009 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
Ventricular Tachycardia Hospitalization 12/25/2008 Male 190 lb 9/1/2009 Other Health Professional United States
Primary
Secondary
Concomitant
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
Myocardial Infarction Other Serious 8/4/2007 Male 9/7/2009 Physician United States
Primary
Secondary
Concomitant
Asphyxia Hospitalization 11/29/2008 42 9/7/2009 Physician Russian Federation
Primary
Secondary
Cholecystitis Disability 8/7/2009 71 9/4/2009 Physician United Kingdom
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
Death Death 8/8/2009 68 9/4/2009 Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Ventricular Fibrillation Death 8/25/2009 82 9/4/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Trigeminal Neuralgia Other Serious 4/12/2006 58 9/10/2009 Physician Spain
Primary
Secondary
Concomitant
Vision Blurred Hospitalization 2/27/2009 Female 245 lb 9/10/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 6/22/2008 72 9/10/2009 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Cholecystitis Disability 8/7/2009 71 9/9/2009 Physician United Kingdom
Primary
Secondary
Hypercalcaemia Life Threatening 3/19/2009 71 9/11/2009 Physician Romania
Primary
Secondary
Concomitant
Renal Failure Other Serious 4/16/2009 Male 225 lb 9/14/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Ventricular Fibrillation Death 8/25/2009 82 9/15/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Colon Cancer Life Threatening 8/10/2009 65 9/16/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Dyspnoea Other Serious 6/9/2009 Female 180 lb 9/15/2009 Physician United States
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 7/14/2009 72 9/15/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Atrioventricular Block Complete Other Serious 9/4/2009 Female 193 lb 9/16/2009 United States
Primary
Secondary
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
Cerebral Infarction Hospitalization 8/31/2009 77 9/15/2009 Physician Korea, Republic Of
Primary
Secondary
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
Oedema Peripheral Hospitalization 10/13/2008 Female 203 lb 9/18/2009 Physician United States
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
Dyspnoea Other Serious 6/9/2009 Female 180 lb 9/21/2009 Other Health Professional United States
Primary
Secondary
Concomitant
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
Arrhythmia Hospitalization 9/8/2009 98 9/23/2009 Other Health Professional Sweden
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
Cerebrovascular Accident Hospitalization 3/29/2009 67 9/24/2009 Other Health Professional United Kingdom
Primary
Secondary
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

Drug Data