Blinded NO Treatment Received combined with Placebo

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Respiratory Tract Infection Life Threatening 12/7/2010 51 Female 179 lb 12/31/2010 Physician Brazil
Primary
Secondary
Concomitant
Stomatitis Hospitalization 8/7/2010 49 Female 150 lb 12/31/2010 Physician United Kingdom
Primary
Secondary
Arthralgia Hospitalization 5/22/2010 13 Male 126 lb 1/6/2011 Physician Netherlands
Primary
Secondary
Convulsion Other Serious 10/17/2010 15 Female 176 lb 1/10/2011 Physician United States
Primary
Secondary
Concomitant
Malaise Hospitalization 12/23/2010 9 Male 44 lb 1/11/2011 Physician Belgium
Primary
Secondary
Concomitant
Anaemia Hospitalization 12/22/2010 56 Male 176 lb 1/12/2011 Physician Spain
Primary
Secondary
Fluid Overload Hospitalization 12/13/2009 90 Female 95 lb 1/17/2011 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Abnormal Faeces Hospitalization 12/22/2010 9 Male 44 lb 1/17/2011 Physician Belgium
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 12/1/2010 38 Male 170 lb 1/19/2011 Physician France
Primary
Secondary
Concomitant
Abnormal Faeces Hospitalization 12/22/2010 9 Male 44 lb 1/24/2011 Physician Belgium
Primary
Secondary
Concomitant
Anaemia Death 12/22/2010 56 Male 176 lb 1/26/2011 Physician Spain
Primary
Secondary
Concomitant
Drug Intolerance Other Serious 3/3/2011 78 Male 203 lb 5/6/2011 Physician Ireland
Primary
Secondary
Concomitant
Fatigue Hospitalization 4/7/2011 Male 5/17/2011 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/8/2010 55 Male 241 lb 5/20/2011 Physician United States
Primary
Secondary
Concomitant
Depression Hospitalization 4/7/2011 Male 5/18/2011 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Rash Other Serious 4/4/2011 68 Male 234 lb 5/24/2011 Physician Australia
Primary
Secondary
Concomitant
Cerebrovascular Accident Hospitalization 4/2/2011 74 Male 220 lb 5/25/2011 Physician Denmark
Primary
Secondary
Concomitant
Lymphadenopathy Other Serious 5/26/2011 8 Male 71 lb 6/2/2011 Physician France
Primary
Secondary
Oesophageal Stenosis Hospitalization 4/27/2011 64 Female 185 lb 6/14/2011 Physician United States
Primary
Secondary
Bradycardia Hospitalization 3/26/2011 64 Female 226 lb 6/14/2011 Physician United States
Primary
Secondary
Concomitant
Sinus Disorder Other Serious 6/1/2011 58 119 lb 6/16/2011 Physician Taiwan, Province Of China
Primary
Secondary
Oesophageal Stenosis Hospitalization 4/27/2011 64 Female 185 lb 6/17/2011 Physician United States
Primary
Secondary
Lung Disorder Hospitalization 5/18/2011 6 Female 49 lb 6/20/2011 Physician Hungary
Primary
Secondary
Rhinitis Other Serious 5/26/2011 8 Male 73 lb 6/23/2011 Physician France
Primary
Secondary
Fatigue Hospitalization 4/7/2011 Male 6/24/2011 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Intestinal Perforation Other Serious 4/27/2011 64 Female 185 lb 6/27/2011 Physician United States
Primary
Secondary
Enteritis Hospitalization 4/8/2010 55 Male 241 lb 6/28/2011 Physician United States
Primary
Secondary
Concomitant
Bronchopneumonia Hospitalization 5/18/2011 6 Female 49 lb 6/29/2011 Physician Hungary
Primary
Secondary
Concomitant
Intestinal Perforation Hospitalization 4/27/2011 64 Female 185 lb 6/30/2011 Physician United States
Primary
Secondary
Fatigue Hospitalization 4/2/2011 74 Male 220 lb 7/11/2011 Physician Denmark
Primary
Secondary
Concomitant
Death Hospitalization Male 157 lb 7/12/2011 Physician Argentina
Primary
Secondary
Concomitant
Polydipsia Hospitalization 3/5/2011 61 Female 95 lb 7/12/2011 Physician Japan
Primary
Secondary
Concomitant
Haemoptysis Hospitalization 5/26/2011 20 Male 192 lb 7/13/2011 Physician Poland
Primary
Secondary
Concomitant
Pneumonia Death Male 157 lb 7/13/2011 Physician Argentina
Primary
Secondary
Concomitant
Headache Hospitalization 5/22/2010 13 Male 126 lb 7/1/2011 Physician Netherlands
Primary
Secondary
Injury Hospitalization 4/6/2011 7 Male 52 lb 6/28/2011 Physician Russian Federation
Primary
Secondary
Concomitant Disease Progression Disability 5/24/2011 39 Female 126 lb 7/14/2011 Physician Brazil
Primary
Secondary
Concomitant
Disease Progression Hospitalization 5/26/2011 20 Male 192 lb 7/18/2011 Physician Poland
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/23/2011 75 Male 139 lb 7/20/2011 Physician Japan
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 6/27/2011 61 Male 165 lb 7/20/2011 Physician Spain
Primary
Secondary
Concomitant
Peripheral Ischaemia Hospitalization 5/1/2011 74 Male 165 lb 7/20/2011 Physician United Kingdom
Primary
Secondary
Dysplasia Hospitalization 5/26/2011 20 Male 192 lb 7/21/2011 Physician Poland
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 3/5/2011 61 Female 95 lb 7/26/2011 Physician Japan
Primary
Secondary
Concomitant
Swelling Hospitalization 12/22/2010 9 Male 44 lb 7/27/2011 Physician Belgium
Primary
Secondary
Concomitant
Syncope Hospitalization 7/15/2011 61 Female 187 lb 8/1/2011 Physician United States
Primary
Secondary
Diarrhoea Other Serious 3/3/2011 78 Male 203 lb 8/2/2011 Physician Ireland
Primary
Secondary
Concomitant
Dysplasia Other Serious 5/26/2011 20 Male 192 lb 8/8/2011 Physician Poland
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization 3/5/2011 61 Female 95 lb 8/10/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Hospitalization 1/31/2011 4 Female 39 lb 8/11/2011 Physician Netherlands
Primary
Secondary
Concomitant
Dysplasia Hospitalization 5/26/2011 20 Male 192 lb 8/15/2011 Physician Poland
Primary
Secondary
Concomitant
Infection Hospitalization 8/10/2011 Female 133 lb 8/19/2011 Physician Greece
Primary
Secondary
Haemorrhage Hospitalization 8/9/2011 70 Male 197 lb 8/23/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Disease Progression Hospitalization 5/26/2011 20 Male 192 lb 8/24/2011 Physician Poland
Primary
Secondary
Concomitant
Arrhythmia Hospitalization 11/12/2010 71 Male 172 lb 8/24/2011 Physician China
Primary
Secondary
Arrhythmia Hospitalization 11/12/2010 71 Male 172 lb 9/2/2011 Physician China
Primary
Secondary
Jaundice Cholestatic Hospitalization 4/13/2011 73 Male 186 lb 9/9/2011 Other Health Professional United States
Primary
Secondary
Cardiac Failure Congestive Disability 9/1/2011 64 Female 142 lb 9/23/2011 Physician Guatemala
Primary
Secondary
Concomitant
Presyncope Hospitalization 10/23/2010 76 Male 184 lb 9/26/2011 Physician Sweden
Primary
Secondary
Cellulitis Hospitalization 11/10/2011 62 Female 247 lb 11/21/2011 Physician United States
Primary
Secondary
Hypertriglyceridaemia Hospitalization 11/18/2011 52 Female 132 lb 11/22/2011 Physician Romania
Primary
Secondary
Concomitant
Pneumonia Hospitalization 12/1/2011 38 Female 137 lb 12/15/2011 Physician Germany
Primary
Secondary
Dysplasia Hospitalization 5/26/2011 20 Male 192 lb 12/22/2011 Other Health Professional Poland
Primary
Secondary
Concomitant
Osteoporosis Hospitalization 11/29/2011 55 Male 106 lb 12/26/2011 Physician Argentina
Primary
Secondary
Concomitant
Pulmonary Congestion Hospitalization 12/17/2011 70 Male 174 lb 12/29/2011 Physician Israel
Primary
Secondary
Concomitant Disease Progression Hospitalization 10/24/2011 46 Female 199 lb 1/5/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 12/9/2011 47 Male 225 lb 1/9/2012 Other Health Professional Belgium
Primary
Secondary
Concomitant
Renal Failure Other Serious 8/12/2011 77 Female 114 lb 1/9/2012 Physician Colombia
Primary
Secondary
Vertigo Positional Hospitalization 12/27/2011 24 Female 207 lb 1/24/2012 Physician Germany
Primary
Secondary
Concomitant
Condition Aggravated Hospitalization 9/23/2011 30 Female 132 lb 1/25/2012 Physician Germany
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 12/24/2011 67 Male 159 lb 1/31/2012 Physician Japan
Primary
Secondary
Concomitant
Cholecystitis Chronic Hospitalization 9/23/2011 64 Female 290 lb 1/31/2012 Physician United States
Primary
Secondary
Concomitant
Angina Pectoris Hospitalization 12/30/2011 65 Male 294 lb 2/3/2012 Physician United States
Primary
Secondary
Concomitant Disease Progression Hospitalization 2/8/2012 81 Male 171 lb 2/17/2012 Physician Italy
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 8/13/2010 56 Male 181 lb 2/23/2012 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 12/1/2011 38 Female 137 lb 2/28/2012 Physician Germany
Primary
Secondary
Laryngeal Oedema Other Serious 2/23/2012 44 Male 194 lb 3/1/2012 Physician Germany
Primary
Secondary
Concomitant
Hypotension Hospitalization 10/19/2011 70 Male 136 lb 3/2/2012 Physician Canada
Primary
Secondary
Concomitant
Paraesthesia Other Serious 7/28/2010 77 Female 3/2/2012 Physician United States
Primary
Secondary
Toxicity To Various Agents Hospitalization 1/8/2012 67 Female 215 lb 3/2/2012 Physician Sweden
Primary
Secondary
Concomitant
Septic Shock Other Serious 12/22/2011 65 Male 154 lb 3/14/2012 Physician France
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 2/11/2012 72 Female 192 lb 3/21/2012 Physician Singapore
Primary
Secondary
Dyspepsia Hospitalization 12/14/2010 71 Female 127 lb 3/21/2012 Other Health Professional Poland
Primary
Secondary
Concomitant
Neutropenic Sepsis Hospitalization 12/30/2011 34 Female 3/22/2012 Physician United Kingdom
Primary
Secondary
Tremor Hospitalization 1/8/2012 67 Female 215 lb 3/22/2012 Physician Sweden
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 2/23/2011 58 Female 132 lb 3/23/2012 Physician South Africa
Primary
Secondary
Concomitant
Cough Hospitalization 12/7/2010 51 Female 179 lb 3/27/2012 Physician Brazil
Primary
Secondary
Concomitant
Headache Hospitalization 12/4/2011 53 Female 301 lb 3/27/2012 Consumer United States
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 11/3/2011 65 Female 144 lb 3/29/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Dysplasia Other Serious 11/1/2009 65 Male 183 lb 4/4/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 12/7/2011 47 Male 225 lb 4/4/2012 Physician Belgium
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 12/7/2011 47 Male 225 lb 4/4/2012 Physician Belgium
Primary
Secondary
Concomitant
Septic Shock Other Serious 12/22/2011 65 Male 154 lb 4/5/2012 Physician France
Primary
Secondary
Concomitant
Dizziness Hospitalization 11/16/2011 52 Male 165 lb 4/10/2012 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 3/8/2012 48 Female 137 lb 4/12/2012 Physician Lebanon
Primary
Secondary
Concomitant
Bursitis Hospitalization 9/19/2011 58 Male 167 lb 4/13/2012 Physician United States
Primary
Secondary
Disease Progression Hospitalization 11/2/2011 65 Female 144 lb 4/13/2012 Physician United States
Primary
Secondary
Concomitant
Alcohol Abuse Hospitalization 4/6/2012 61 Female 95 lb 4/16/2012 Physician Germany
Primary
Secondary
Concomitant
Familial Hypocalciuric Hypercalcaemia Hospitalization 3/23/2012 73 Female 193 lb 4/16/2012 Other Health Professional Canada
Primary
Secondary
Concomitant
Coronary Artery Disease Other Serious 3/9/2011 67 Female 188 lb 4/16/2012 Physician United States
Primary
Secondary
Croup Infectious Other Serious 8/14/2011 1 Female 25 lb 4/18/2012 Other Health Professional Canada
Primary
Secondary
Concomitant
Pseudomonas Infection Hospitalization 4/30/2011 Female 13 lb 4/18/2012 Physician Canada
Primary
Secondary
Renal Failure Acute Hospitalization 11/30/2011 52 Female 114 lb 4/19/2012 Physician Korea, Republic Of
Primary
Secondary
Pneumonitis Hospitalization 1/8/2012 69 Female 117 lb 4/19/2012 Physician China
Primary
Secondary
Intestinal Adenocarcinoma Other Serious 3/23/2012 73 Male 144 lb 4/20/2012 Physician Canada
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 5/23/2011 75 Male 139 lb 4/26/2012 Physician Japan
Primary
Secondary
Concomitant
Hepatic Neoplasm Malignant Other Serious 2/14/2011 66 Male 201 lb 5/2/2012 Physician Japan
Primary
Secondary
Concomitant
Musculoskeletal Stiffness Other Serious 11/17/2011 56 Female 5/4/2012 Physician United Kingdom
Primary
Secondary
Disease Progression Hospitalization 11/2/2011 65 Female 144 lb 5/4/2012 Physician United States
Primary
Secondary
Concomitant
Overdose Hospitalization 10/24/2011 46 Female 199 lb 5/8/2012 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 10/17/2011 66 Male 209 lb 5/8/2012 Physician United States
Primary
Secondary
Concomitant
Hepatic Neoplasm Malignant Other Serious 2/14/2011 66 Male 201 lb 5/8/2012 Physician Japan
Primary
Secondary
Concomitant
Hypertension Hospitalization 8/14/2011 1 Female 25 lb 5/9/2012 Other Health Professional Canada
Primary
Secondary
Concomitant
Gastritis Hospitalization 1/10/2012 63 Female 225 lb 5/10/2012 Physician South Africa
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/5/2012 59 Female 100 lb 5/9/2012 Other Health Professional Korea, Republic Of
Primary
Secondary
Proteinuria Hospitalization 6/17/2011 30 Female 130 lb 5/10/2012 Physician Germany
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/23/2011 53 Male 139 lb 5/9/2012 Other Health Professional China
Primary
Secondary
Haemorrhage Hospitalization 11/4/2009 65 Male 183 lb 5/10/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Cerebrovascular Accident Disability 11/7/2011 98 Female 5/11/2012 Physician France
Primary
Secondary
Concomitant
Drug Interaction Other Serious 11/28/2011 53 Male 210 lb 5/14/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Interacting
Suicidal Ideation Hospitalization 10/24/2011 46 Female 199 lb 5/14/2012 Physician United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 3/1/2012 63 Male 243 lb 5/17/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 3/1/2012 63 Male 243 lb 5/17/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 11/2/2011 65 Female 148 lb 5/16/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 9/8/2011 58 Male 113 lb 5/18/2012 Physician United States
Primary
Secondary
Concomitant
Anxiety Other Serious 11/28/2011 53 Male 210 lb 5/21/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Interacting
Musculoskeletal Stiffness Other Serious 11/17/2011 56 Female 5/21/2012 Physician United Kingdom
Primary
Secondary
Osteonecrosis Of Jaw Hospitalization 12/15/2011 49 Male 191 lb 5/23/2012 Physician Germany
Primary
Secondary
Concomitant
Cholelithiasis Hospitalization 9/23/2011 64 Female 290 lb 5/23/2012 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/5/2012 70 Male 176 lb 5/24/2012 Physician Italy
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 12/14/2010 71 Female 127 lb 5/29/2012 Other Health Professional Poland
Primary
Secondary
Concomitant
Sarcoidosis Other Serious 5/6/2009 62 Male 218 lb 6/1/2012 Physician Netherlands
Primary
Secondary
Concomitant
Abdominal Pain Other Serious 3/3/2011 78 Male 203 lb 6/1/2012 Physician Ireland
Primary
Secondary
Concomitant
Blood Chloride Decreased Hospitalization 8/9/2011 68 Male 160 lb 6/5/2012 Physician Spain
Primary
Secondary
Concomitant
Retrograde Amnesia Hospitalization 4/18/2012 63 Female 129 lb 6/6/2012 Consumer Germany
Primary
Secondary
Concomitant
Hypotension Disability 10/19/2011 70 Male 136 lb 6/6/2012 Physician Canada
Primary
Secondary
Concomitant
Bursitis Hospitalization 9/27/2011 58 Male 167 lb 6/8/2012 Physician United States
Primary
Secondary
Rectal Cancer Other Serious 12/15/2011 60 Male 179 lb 6/8/2012 Physician United States
Primary
Secondary
Anxiety Other Serious 11/28/2011 53 Male 210 lb 6/8/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Interacting
Breast Hypoplasia Hospitalization 9/9/2011 37 Female 140 lb 6/11/2012 Other Health Professional France
Primary
Secondary
Headache Hospitalization 12/4/2011 53 Female 301 lb 6/12/2012 Physician United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 3/9/2012 Female 54 lb 6/13/2012 Physician United States
Primary
Secondary
Mucosal Infection Life Threatening 6/4/2012 45 Female 137 lb 6/13/2012 Physician China
Primary
Secondary
Diarrhoea Hospitalization 10/27/2011 78 Male 298 lb 6/14/2012 Physician Italy
Primary
Secondary
Concomitant
Salmonellosis Hospitalization 5/21/2012 81 Male 150 lb 6/18/2012 Physician Italy
Primary
Secondary
Concomitant
Appendicitis Hospitalization 4/15/2011 30 Male 181 lb 6/19/2012 Physician Netherlands
Primary
Secondary
Breast Hypoplasia Hospitalization 9/9/2011 37 Female 140 lb 6/20/2012 Physician France
Primary
Secondary
Concomitant Disease Progression Hospitalization 6/10/2011 67 Male 256 lb 6/20/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Anaemia Hospitalization 2/8/2012 81 Male 171 lb 6/20/2012 Physician Italy
Primary
Secondary
Concomitant
Coronary Artery Disease Other Serious 5/6/2009 62 Male 218 lb 6/20/2012 Physician Netherlands
Primary
Secondary
Concomitant
Musculoskeletal Stiffness Other Serious 11/17/2011 56 Female 6/22/2012 Physician United Kingdom
Primary
Secondary

Drug Data