Blinded NO Treatment Received combined with Blinded Placebo

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Drug Interaction Hospitalization 12/3/2010 61 Male 168 lb 1/5/2011 Physician Colombia
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Hospitalization 12/23/2010 9 Male 44 lb 1/5/2011 Physician Belgium
Primary
Secondary
Concomitant
Pyrexia Hospitalization 1/8/2011 4 Male 40 lb 1/27/2011 Physician Germany
Primary
Secondary
Hepatic Enzyme Increased Other Serious 12/1/2010 10 Female 82 lb 1/28/2011 Physician Greece
Primary
Secondary
Pyrexia Other Serious 12/22/2010 9 Male 44 lb 2/2/2011 Physician Belgium
Primary
Secondary
Concomitant
Convulsion Other Serious 10/17/2010 15 Female 176 lb 2/2/2011 Physician United States
Primary
Secondary
Concomitant
Abdominal Pain Upper Hospitalization 11/1/2010 17 Female 2/7/2011 Physician Canada
Primary
Secondary
Concomitant
Endotracheal Intubation Hospitalization 10/17/2010 15 Female 176 lb 2/7/2011 Physician United States
Primary
Secondary
Concomitant
Speech Disorder Other Serious Female 2/10/2011 Physician United States
Primary
Secondary
Pyrexia Hospitalization 1/31/2011 4 Female 39 lb 2/10/2011 Physician Netherlands
Primary
Secondary
Concomitant
Aphasia Hospitalization 4/8/2010 88 Female 121 lb 2/11/2011 Physician United States
Primary
Secondary
Concomitant
Pharyngitis Other Serious 12/1/2010 10 Female 82 lb 2/11/2011 Physician Greece
Primary
Secondary
Abdominal Pain Hospitalization 1/29/2011 59 Male 224 lb 2/14/2011 Physician United States
Primary
Secondary
Concomitant
Dizziness Hospitalization 10/23/2010 76 Male 184 lb 2/16/2011 Physician Sweden
Primary
Secondary
Escherichia Urinary Tract Infection Hospitalization 11/1/2010 17 Female 2/15/2011 Physician Canada
Primary
Secondary
Concomitant
Arthralgia Hospitalization 1/31/2011 4 Female 39 lb 2/28/2011 Physician Netherlands
Primary
Secondary
Concomitant
Arrhythmia Hospitalization 11/12/2010 71 Male 172 lb 2/28/2011 Physician China
Primary
Secondary
Coronary Arterial Stent Insertion Hospitalization 12/22/2010 38 Male 170 lb 3/3/2011 Physician France
Primary
Secondary
Concomitant
Pruritus Hospitalization 8/13/2010 60 Male 225 lb 3/4/2011 Physician United States
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization 11/12/2010 71 Male 172 lb 3/15/2011 Physician China
Primary
Secondary
Abdominal Pain Other Serious 3/3/2011 78 Male 203 lb 3/25/2011 Physician Ireland
Primary
Secondary
Concomitant
Cardiac Pacemaker Insertion Hospitalization 12/3/2010 61 Male 168 lb 3/28/2011 Physician Colombia
Primary
Secondary
Concomitant
Abdominal Pain Hospitalization 1/29/2011 59 Male 224 lb 3/31/2011 Physician United States
Primary
Secondary
Concomitant
Sudden Death Death 2/21/2011 35 Male 143 lb 3/30/2011 Physician Argentina
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 3/23/2011 56 Male 207 lb 4/4/2011 Physician Germany
Primary
Secondary
Breath Sounds Abnormal Other Serious 12/13/2009 90 Female 95 lb 4/4/2011 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Mucosal Inflammation Hospitalization 4/14/2010 62 Male 97 lb 4/13/2011 Physician Japan
Primary
Secondary
Abdominal Pain Other Serious 3/3/2011 78 Male 203 lb 4/17/2011 Physician Ireland
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Hospitalization 1/31/2011 4 Female 39 lb 5/3/2011 Physician Netherlands
Primary
Secondary
Concomitant
Complex Partial Seizures Hospitalization 5/31/2011 13 Male 120 lb 7/1/2011 Physician United States
Primary
Concomitant
Interacting
Drug Interaction Hospitalization 5/31/2011 13 Male 120 lb 7/5/2011 Physician United States
Primary
Concomitant
Interacting
Fatigue Hospitalization 3/5/2011 61 Female 95 lb 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Rhinitis Other Serious 5/26/2011 8 Male 73 lb 7/8/2011 Physician France
Primary
Secondary
Disease Progression Hospitalization 5/26/2011 20 Male 192 lb 8/3/2011 Other Health Professional Poland
Primary
Secondary
Concomitant
Drug Ineffective Hospitalization 1/31/2011 4 Female 39 lb 8/8/2011 Physician Netherlands
Primary
Secondary
Concomitant
Disease Progression Hospitalization 7/10/2011 84 Female 175 lb 9/5/2011 Physician United States
Primary
Secondary
Concomitant
Red Blood Cell Sedimentation Rate Increased Hospitalization 8/28/2010 7 Female 40 lb 9/9/2011 Physician Romania
Primary
Secondary
Concomitant
Renal Failure Other Serious 8/12/2011 77 Female 114 lb 9/13/2011 Physician Colombia
Primary
Secondary
Concomitant Disease Progression Hospitalization 9/3/2011 64 Female 142 lb 9/16/2011 Physician Guatemala
Primary
Secondary
Concomitant
Laryngitis Hospitalization 8/15/2011 1 Female 25 lb 9/16/2011 Other Health Professional Canada
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 7/14/2011 61 Female 187 lb 9/16/2011 Physician United States
Primary
Secondary
Red Blood Cell Sedimentation Rate Increased Hospitalization 8/28/2010 7 Female 40 lb 9/16/2011 Physician Romania
Primary
Secondary
Concomitant
Blood Chloride Decreased Hospitalization 8/9/2011 68 Male 160 lb 9/19/2011 Physician Spain
Primary
Secondary
Concomitant
Dehydration Life Threatening 8/22/2011 87 Female 128 lb 9/20/2011 Physician Belgium
Primary
Secondary
Concomitant Disease Progression Death 9/14/2011 72 Male 144 lb 9/22/2011 Physician Russian Federation
Primary
Secondary
Concomitant
Hyperhidrosis Hospitalization 8/31/2010 66 Male 9/26/2011 Physician United States
Primary
Secondary
Concomitant
Urosepsis Death 3/25/2011 16 Female 57 lb 9/26/2011 Physician Brazil
Primary
Secondary
Concomitant
Acute Coronary Syndrome Hospitalization 9/19/2011 66 Male 183 lb 9/28/2011 Physician Turkey
Primary
Secondary
Concomitant
Renal Failure Chronic Other Serious Male 160 lb 9/30/2011 Physician Spain
Primary
Secondary
Concomitant
Cytolytic Hepatitis Hospitalization 9/6/2011 42 Female 123 lb 10/6/2011 Physician Belgium
Primary
Secondary
Oedema Hospitalization 12/13/2009 69 Female 119 lb 10/6/2011 Physician Japan
Primary
Secondary
Concomitant
Peripheral Vascular Disorder Hospitalization 8/8/2011 78 Female 157 lb 10/10/2011 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Peripheral Vascular Disorder Hospitalization 8/8/2011 78 Female 157 lb 10/10/2011 Physician Netherlands
Primary
Secondary
Concomitant
Cardiac Failure Congestive Other Serious 9/1/2011 64 Female 142 lb 10/13/2011 Physician Guatemala
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 8/28/2011 57 Male 196 lb 10/19/2011 Physician France
Primary
Secondary
Pallor Hospitalization 9/14/2010 62 Female 173 lb 10/20/2011 Physician South Africa
Primary
Secondary
Concomitant
Cardiac Failure Congestive Death 9/14/2010 62 Female 173 lb 10/20/2011 Physician South Africa
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 9/28/2011 75 Male 205 lb 10/25/2011 Physician Netherlands
Primary
Secondary
Concomitant
Pleural Effusion Death 9/14/2010 62 Female 173 lb 10/25/2011 Physician South Africa
Primary
Secondary
Concomitant
Cardiac Arrest Hospitalization 10/12/2011 81 Male 167 lb 10/26/2011 Physician United States
Primary
Secondary
Vomiting Hospitalization 9/9/2010 69 Female 163 lb 11/2/2011 Physician Spain
Primary
Secondary
Chronic Obstructive Pulmonary Disease Hospitalization 10/23/2011 52 Female 119 lb 11/3/2011 Physician Spain
Primary
Secondary
Concomitant
Hypotension Hospitalization 10/12/2011 81 Male 167 lb 11/3/2011 Physician United States
Primary
Secondary
Fatigue Hospitalization 3/5/2011 61 Female 95 lb 11/4/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 9/28/2011 75 Male 205 lb 11/8/2011 Physician Netherlands
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 7/10/2011 84 Female 175 lb 11/8/2011 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/28/2011 60 Female 127 lb 11/11/2011 Physician Argentina
Primary
Secondary
Hypokalaemia Disability 10/28/2011 50 Female 137 lb 11/11/2011 Other Health Professional Brazil
Primary
Secondary
Renal Failure Hospitalization 10/28/2011 78 Male 298 lb 11/11/2011 Physician Italy
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 8/8/2011 78 Female 157 lb 11/15/2011 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 8/8/2011 78 Female 157 lb 11/15/2011 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Musculoskeletal Pain Hospitalization 9/6/2011 64 Female 290 lb 11/16/2011 Physician United States
Primary
Secondary
Concomitant
Acute Respiratory Failure Hospitalization 10/18/2011 68 Female 149 lb 11/21/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Lymphopenia Hospitalization 11/13/2011 53 Female 146 lb 11/25/2011 Physician Germany
Primary
Secondary
Concomitant
Adenocarcinoma Hospitalization 10/15/2011 73 Male 190 lb 11/28/2011 Other Health Professional Australia
Primary
Secondary
Cholecystitis Acute Hospitalization 8/6/2011 46 Male 137 lb 11/28/2011 Physician Japan
Primary
Secondary
Dizziness Hospitalization 11/7/2011 76 Male 133 lb 11/28/2011 Physician Ireland
Primary
Secondary
Concomitant
Hypokalaemia Disability 10/28/2011 50 Female 137 lb 11/28/2011 Other Health Professional Brazil
Primary
Secondary
Cholecystitis Hospitalization 3/31/2011 64 Female 137 lb 11/28/2011 Physician Brazil
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 9/14/2010 62 Female 173 lb 11/29/2011 Physician South Africa
Primary
Secondary
Concomitant
Hypokalaemia Hospitalization 10/28/2011 50 Female 137 lb 11/29/2011 Physician Brazil
Primary
Secondary
Septic Shock Hospitalization 8/28/2011 57 Male 196 lb 11/30/2011 Other Health Professional France
Primary
Secondary
Fatigue Hospitalization 4/24/2011 73 Female 139 lb 11/30/2011 Other Health Professional Germany
Primary
Secondary
Alanine Aminotransferase Increased Other Serious 2/23/2011 58 Female 132 lb 11/30/2011 Physician South Africa
Primary
Secondary
Concomitant
Anaemia Other Serious 12/13/2009 69 Female 119 lb 11/30/2011 Physician Japan
Primary
Secondary
Concomitant
Dizziness Hospitalization 11/7/2011 76 Male 133 lb 12/1/2011 Physician Ireland
Primary
Secondary
Concomitant
Paraesthesia Hospitalization 7/28/2010 77 Female 12/1/2011 Physician United States
Primary
Secondary
Hypertension Other Serious 11/17/2011 56 Female 12/1/2011 Physician United Kingdom
Primary
Secondary
Epistaxis Other Serious 12/13/2009 69 Female 119 lb 12/2/2011 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 5/27/2011 59 Female 108 lb 12/5/2011 Physician China
Primary
Secondary
Fistula Hospitalization 9/27/2011 28 Male 247 lb 12/7/2011 Physician Germany
Primary
Secondary
Pneumonia Hospitalization 11/3/2011 41 Female 148 lb 12/7/2011 Physician Netherlands
Primary
Secondary
Concomitant
Bile Duct Stone Other Serious 8/6/2011 46 Male 137 lb 12/8/2011 Physician Japan
Primary
Secondary
Thrombocytopenia Hospitalization 11/28/2011 60 Male 242 lb 12/8/2011 Other Health Professional United States
Primary
Secondary
Neoplasm Malignant Hospitalization 9/23/2011 30 Female 132 lb 12/8/2011 Physician Germany
Primary
Secondary
Concomitant
Diarrhoea Disability 10/28/2011 50 Female 137 lb 12/9/2011 Other Health Professional Brazil
Primary
Secondary
Dehydration Hospitalization 9/14/2010 62 Female 173 lb 12/9/2011 Physician South Africa
Primary
Secondary
Concomitant
Cholelithiasis Hospitalization 9/23/2011 64 Female 290 lb 12/8/2011 Physician United States
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 11/24/2011 80 Female 102 lb 12/11/2011 Physician Guatemala
Primary
Secondary
Concomitant
Abscess Hospitalization 9/27/2011 28 Male 247 lb 12/12/2011 Physician Germany
Primary
Secondary
Staphylococcal Infection Hospitalization 12/8/2011 7 Female 56 lb 12/12/2011 Physician Hungary
Primary
Secondary
Concomitant
Sepsis Hospitalization 7/19/2011 33 Female 150 lb 12/13/2011 Physician Germany
Primary
Secondary
Concomitant
Cardiac Failure Congestive Hospitalization 7/19/2011 33 Female 150 lb 12/14/2011 Physician Germany
Primary
Secondary
Concomitant
Anaemia Hospitalization 3/2/2010 36 Male 165 lb 12/15/2011 Physician Germany
Primary
Secondary
Concomitant
Haematuria Hospitalization 12/4/2011 68 Male 228 lb 12/16/2011 Physician Argentina
Primary
Secondary
Hyperlipasaemia Hospitalization 8/18/2011 52 Female 132 lb 12/19/2011 Physician Romania
Primary
Secondary
Concomitant
Headache Other Serious 11/17/2011 56 Female 12/21/2011 Physician United Kingdom
Primary
Secondary
Rectal Cancer Other Serious 9/2/2011 60 Female 179 lb 12/22/2011 Physician United States
Primary
Secondary
Staphylococcal Infection Hospitalization 11/16/2011 6 Female 56 lb 12/27/2011 Physician Hungary
Primary
Secondary
Concomitant
Pulmonary Congestion Hospitalization 12/17/2011 70 Male 174 lb 12/27/2011 Physician Israel
Primary
Secondary
Drug Interaction Other Serious 11/28/2011 53 Male 210 lb 12/28/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Interacting
Pulmonary Oedema Hospitalization 12/5/2011 65 Male 1/2/2012 Physician Japan
Primary
Secondary
Concomitant
Cerumen Impaction Hospitalization 11/27/2011 53 Male 364 lb 1/3/2012 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 12/4/2011 68 Male 228 lb 1/10/2012 Physician Argentina
Primary
Secondary
Small Intestinal Obstruction Hospitalization 11/15/2011 55 Male 143 lb 1/11/2012 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Blood Urine Present Hospitalization 11/30/2011 57 Female 174 lb 1/12/2012 Physician Denmark
Primary
Secondary
Condition Aggravated Hospitalization 9/23/2011 30 Female 132 lb 1/14/2012 Physician Germany
Primary
Secondary
Concomitant
Renal Failure Chronic Other Serious 12/28/2011 63 Female 134 lb 1/17/2012 Physician Brazil
Primary
Secondary
Gastrointestinal Haemorrhage Hospitalization 10/15/2011 73 Male 190 lb 1/17/2012 Other Health Professional Australia
Primary
Secondary
Concomitant
Depression Other Serious 11/28/2011 53 Male 210 lb 1/17/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Interacting
Vertigo Positional Hospitalization 12/27/2011 24 Female 207 lb 1/17/2012 Physician Germany
Primary
Secondary
Concomitant
Lymphopenia Other Serious 11/11/2011 53 Female 146 lb 1/18/2012 Physician Germany
Primary
Secondary
Concomitant
Nasopharyngitis Life Threatening 7/28/2011 57 Male 130 lb 1/19/2012 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 10/24/2011 46 Female 199 lb 1/20/2012 Physician United States
Primary
Secondary
Concomitant
Disease Progression Hospitalization 12/5/2011 65 Male 1/17/2012 Physician Japan
Primary
Secondary
Concomitant
Fall Hospitalization 8/14/2010 56 Male 176 lb 1/23/2012 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Klebsiella Hospitalization 11/1/2011 63 Female 190 lb 1/24/2012 Physician Belgium
Primary
Secondary
Concomitant
Renal Failure Chronic Other Serious 12/28/2011 63 Female 128 lb 1/25/2012 Physician Brazil
Primary
Secondary
Concomitant Disease Progression Hospitalization 12/7/2011 47 Male 225 lb 1/25/2012 Physician Belgium
Primary
Secondary
Concomitant
Disease Progression Hospitalization 11/11/2011 53 Female 146 lb 2/2/2012 Physician Germany
Primary
Secondary
Concomitant
Chest Pain Hospitalization 1/4/2012 68 Male 192 lb 2/6/2012 Physician Argentina
Primary
Secondary
Azotaemia Hospitalization 11/30/2011 57 Female 174 lb 2/6/2012 Physician Denmark
Primary
Secondary
Pneumonia Hospitalization 12/14/2011 64 Male 157 lb 2/8/2012 Physician Germany
Primary
Secondary
Renal Failure Acute Hospitalization 8/13/2010 56 Male 176 lb 2/8/2012 Physician Germany
Primary
Secondary
Concomitant
Cellulitis Hospitalization 11/11/2011 60 Male 173 lb 2/8/2012 Physician United States
Primary
Secondary
Vertigo Positional Hospitalization 12/27/2011 24 Female 207 lb 2/9/2012 Physician Germany
Primary
Secondary
Concomitant
Liver Disorder Other Serious 12/13/2009 69 Female 119 lb 2/10/2012 Physician Japan
Primary
Secondary
Concomitant
Cerumen Impaction Hospitalization 11/27/2011 53 Male 364 lb 2/21/2012 Physician United States
Primary
Secondary
Concomitant
Concussion Hospitalization 1/10/2012 75 Male 151 lb 2/20/2012 Physician Switzerland
Primary
Secondary
Concomitant
Cardiac Failure Congestive Other Serious 12/28/2011 63 Female 131 lb 2/21/2012 Physician Brazil
Primary
Secondary
Dizziness Hospitalization 7/28/2010 77 Female 2/22/2012 Physician United States
Primary
Secondary
Hypertension Hospitalization 1/4/2012 72 Male 281 lb 2/21/2012 Physician United States
Primary
Secondary
Concomitant Disease Progression Hospitalization 3/23/2011 67 Male 154 lb 2/22/2012 Physician Egypt
Primary
Secondary
Concomitant
Hypotension Hospitalization 10/19/2011 70 Male 136 lb 2/22/2012 Physician Canada
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 1/22/2012 57 Female 137 lb 2/22/2012 Physician Czech Republic
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 1/23/2012 52 Female 99 lb 2/22/2012 Physician Italy
Primary
Secondary
Sudden Death Death 2/12/2012 74 Male 152 lb 2/22/2012 Physician Poland
Primary
Secondary
Concomitant
Vertigo Positional Hospitalization 12/27/2011 24 Female 207 lb 2/23/2012 Physician Germany
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 1/2/2012 56 Female 186 lb 2/24/2012 Physician United States
Primary
Secondary
Concomitant
Systemic Inflammatory Response Syndrome Other Serious 1/7/2012 42 Female 181 lb 2/24/2012 Other Health Professional France
Primary
Secondary
Concomitant

Drug Data