Blinded *Placebo combined with Omeprazole

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Arrhythmia Death 11/29/2008 12/11/2008 Physician Italy
Primary
Secondary
Concomitant
Arrhythmia Death 11/29/2008 12/16/2008 Physician Italy
Primary
Secondary
Concomitant
Intestinal Obstruction Hospitalization 9/26/2008 12/19/2008 Physician Cyprus
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 12/10/2008 12/19/2008 Other Health Professional Poland
Primary
Secondary
Concomitant
Splenomegaly Other Serious 1/20/2008 12/22/2008 Other Health Professional Singapore
Primary
Secondary
Concomitant
Anaemia Hospitalization 10/23/2007 12/23/2008 Physician France
Primary
Secondary
Concomitant
Liver Function Test Abnormal Hospitalization 5/28/2008 12/22/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 9/25/2008 12/22/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/10/2008 12/31/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Non-small Cell Lung Cancer Hospitalization 8/19/2008 1/5/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Hallucinations, Mixed Other Serious 12/7/2008 Female 93 lb 1/5/2009 Physician Thailand
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 12/30/2008 Female 135 lb 1/9/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Non-small Cell Lung Cancer Hospitalization 8/19/2008 1/14/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/2/2009 1/15/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 11/9/2007 1/16/2009 Physician Singapore
Primary
Secondary
Concomitant
Tremor Hospitalization 1/8/2009 1/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hallucinations, Mixed Other Serious 12/7/2008 1/21/2009 Physician Thailand
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
Respiratory Failure Other Serious 11/9/2007 1/26/2009 Physician Singapore
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 1/20/2008 1/30/2009 Other Health Professional Singapore
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 12/30/2008 1/30/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Balance Disorder Hospitalization 1/16/2009 2/2/2009 Physician Sweden
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 12/10/2008 2/3/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/28/2009 2/10/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/2/2009 2/11/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Superinfection Life Threatening 12/29/2008 2/16/2009 Physician Spain
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 1/8/2009 2/18/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/28/2009 2/23/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Arrhythmia Death 11/29/2008 2/24/2009 Physician Italy
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 1/7/2008 Male 200 lb 2/24/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Ascites Hospitalization 1/27/2009 2/26/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/2/2009 2/27/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Death Death 2/19/2008 3/4/2009 Physician Poland
Primary
Secondary
Concomitant
Death Death 1/29/2009 3/9/2009 Physician Poland
Primary
Secondary
Concomitant
Vomiting Hospitalization 2/5/2009 3/23/2009 Physician Sweden
Primary
Secondary
Concomitant
Sinus Tachycardia Hospitalization 1/7/2009 Male 200 lb 3/31/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Benign Intracranial Hypertension Hospitalization 3/13/2009 3/30/2009 United Kingdom
Primary
Secondary
Concomitant
Septic Shock Death 3/4/2009 4/3/2009 Physician Italy
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 2/11/2009 4/6/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Atrial Fibrillation Other Serious 3/19/2009 Male 187 lb 4/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Vertigo Hospitalization 2/22/2008 4/20/2009 Other Health Professional Singapore
Primary
Secondary
Concomitant
Aortic Aneurysm Repair Hospitalization 1/1/2005 Male 220 lb 4/20/2009 Physician United States
Primary
Secondary
Concomitant
Haematoma Hospitalization 11/3/2008 4/24/2009 Physician France
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 8/27/2007 Male 262 lb 4/28/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 2/11/2009 5/4/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypothyroidism Other Serious 8/21/2008 5/6/2009 Physician Spain
Primary
Secondary
Concomitant
Atrial Fibrillation Other Serious 3/19/2009 Male 187 lb 5/7/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 3/26/2009 75 5/8/2009 Physician Canada
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/10/2008 71 5/11/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Death Death 2/19/2008 65 5/21/2009 Physician Poland
Primary
Secondary
Concomitant
Intestinal Obstruction Hospitalization 9/26/2008 59 5/22/2009 Physician Cyprus
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 80 6/9/2009 Physician Spain
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 1/7/2009 Male 200 lb 6/10/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Liver Function Test Abnormal Hospitalization 5/28/2008 Female 139 lb 6/10/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 3/26/2009 75 6/11/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 2/11/2009 74 6/11/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neutropenia Other Serious 5/21/2009 59 6/11/2009 Physician Mexico
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/10/2008 71 6/12/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Intestinal Obstruction Hospitalization 9/26/2008 59 6/15/2009 Physician Cyprus
Primary
Secondary
Concomitant
Palpitations Hospitalization 5/26/2009 69 6/16/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Neutropenia Other Serious 5/21/2009 59 6/16/2009 Physician Mexico
Primary
Secondary
Concomitant
Death Death 6/12/2009 80 6/17/2009 Physician Spain
Primary
Secondary
Concomitant
Lymphoma Hospitalization 3/9/2009 49 6/26/2009 Physician Italy
Primary
Secondary
Concomitant
Septic Shock Death 3/4/2009 64 6/30/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Shock Life Threatening 1/21/2009 30 7/3/2009 Other Health Professional Belgium
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 80 7/8/2009 Physician Spain
Primary
Secondary
Concomitant
Death Death 6/12/2009 80 7/8/2009 Physician Spain
Primary
Secondary
Concomitant
Lung Neoplasm Hospitalization 5/16/2005 Male 139 lb 7/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Death Death 6/12/2009 80 7/20/2009 Physician Spain
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 80 7/20/2009 Physician Spain
Primary
Secondary
Concomitant
Facial Palsy Hospitalization 7/6/2009 81 7/28/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 7/6/2009 81 8/4/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
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
Thrombocytopenia Life Threatening 8/8/2009 54 9/1/2009 Physician Poland
Primary
Secondary
Concomitant
Superinfection Life Threatening 12/29/2008 57 9/16/2009 Physician Spain
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
Renal Failure Acute Hospitalization 1/8/2009 73 10/1/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 9/22/2009 Male 140 lb 10/6/2009 Other Health Professional 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
Renal Failure Acute Other Serious 2/11/2009 74 10/14/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 9/22/2009 Male 140 lb 10/19/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 8/13/2009 Male 275 lb 10/22/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 7/14/2009 72 10/27/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 10/30/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
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
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
Non-small Cell Lung Cancer Hospitalization 8/19/2008 64 Male 134 lb 11/16/2009 Other Health Professional Spain
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
Respiratory Tract Infection Other Serious 11/2/2009 26 Male 190 lb 11/20/2009 Physician Latvia
Primary
Secondary
Concomitant
Rectal Ulcer Hospitalization 7/14/2009 72 Male 187 lb 11/23/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Renal Impairment Other Serious 7/25/2008 76 Female 128 lb 11/25/2009 Physician Mexico
Primary
Secondary
Concomitant
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
Thrombocytopenia Life Threatening 8/8/2009 54 12/21/2009 Physician Poland
Primary
Secondary
Concomitant
Prostate Cancer Hospitalization 9/22/2009 Male 140 lb 12/29/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 12/31/2009 58 Male 218 lb 1/14/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Ankle Fracture Other Serious 12/21/2009 74 Female 138 lb 1/19/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Laryngeal Cancer Other Serious 11/25/2009 74 Female 1/19/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/28/2009 61 Male 176 lb 2/2/2010 Physician Poland
Primary
Secondary
Concomitant
Death Death 6/12/2009 80 Male 163 lb 2/3/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 2/1/2010 66 Male 2/11/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 12/31/2009 58 Male 218 lb 2/25/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 2/1/2010 66 Male 2/24/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 1/8/2009 73 Male 2/25/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/29/2010 65 Male 3/5/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 2/11/2009 74 Male 146 lb 3/5/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 2/4/2010 62 Male 3/5/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 11/25/2009 64 Male 150 lb 3/8/2010 Physician Greece
Primary
Secondary
Concomitant
Hypothyroidism Other Serious 8/21/2008 67 Female 110 lb 3/9/2010 Physician Spain
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/29/2010 65 Male 3/15/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Jugular Vein Thrombosis Hospitalization 12/16/2008 66 Female 137 lb 3/17/2010 Other Health Professional Brazil
Primary
Secondary
Concomitant
Vertigo Hospitalization 2/22/2008 59 Female 3/19/2010 Other Health Professional Singapore
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 12/25/2009 64 Male 150 lb 3/23/2010 Physician Greece
Primary
Secondary
Concomitant
Death Death 2/19/2008 65 Male 141 lb 3/26/2010 Physician Poland
Primary
Secondary
Concomitant
Neutropenia Other Serious 5/21/2009 59 Male 194 lb 3/26/2010 Physician Mexico
Primary
Secondary
Concomitant
Intestinal Obstruction Hospitalization 9/26/2008 59 Male 214 lb 3/26/2010 Physician Cyprus
Primary
Secondary
Concomitant
Jugular Vein Thrombosis Hospitalization 12/16/2008 66 Male 137 lb 4/1/2010 Brazil
Primary
Secondary
Concomitant
Arrhythmia Death 11/29/2008 66 Male 198 lb 3/30/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 12/25/2009 64 Male 150 lb 4/9/2010 Physician Greece
Primary
Secondary
Concomitant
Ankle Fracture Other Serious 12/21/2009 74 Female 137 lb 4/7/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hyperkalaemia Hospitalization 3/20/2007 80 Male 181 lb 4/14/2010 Other Health Professional France
Primary
Secondary
Concomitant
Prostate Cancer Hospitalization 12/30/2009 81 Male 150 lb 4/20/2010 Physician Germany
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 4/6/2010 67 Male 181 lb 4/21/2010 Physician Germany
Primary
Secondary
Concomitant
Hypophosphataemia Hospitalization 3/30/2010 56 Female 218 lb 4/28/2010 Physician Sweden
Primary
Secondary
Concomitant
Acute Coronary Syndrome Hospitalization 3/10/2010 78 Male 185 lb 5/7/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Circulatory Collapse Hospitalization 5/3/2010 67 Male 5/13/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Acute Coronary Syndrome Hospitalization 3/10/2010 78 Male 185 lb 5/31/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 3/26/2010 76 Male 143 lb 5/31/2010 Physician Mexico
Primary
Secondary
Concomitant
Circulatory Collapse Hospitalization 5/3/2010 67 Male 6/21/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 2/1/2010 66 Male 6/29/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Metastases To Bone Hospitalization 4/28/2010 75 Male 191 lb 7/1/2010 Other Health Professional Sweden
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 Male 7/9/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 6/20/2010 74 Male 139 lb 7/14/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Intestinal Haemorrhage Hospitalization 6/10/2010 74 Male 183 lb 7/27/2010 Other Health Professional Spain
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 5/2/2009 68 Male 8/2/2010 Other Health Professional Spain
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
Death Death 8/2/2010 53 Male 187 lb 8/13/2010 Physician Poland
Primary
Secondary
Concomitant
Bursitis Hospitalization 6/15/2010 87 Male 181 lb 8/19/2010 Other Health Professional Sweden
Primary
Secondary
Concomitant
Death Death 8/2/2010 53 Male 187 lb 8/23/2010 Physician Poland
Primary
Secondary
Concomitant
Gastrooesophageal Reflux Disease Hospitalization 3/16/2010 75 Female 138 lb 8/25/2010 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

Drug Data