Blinded Aliskiren combined with Blinded NO Treatment Received

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Death Death 12/9/2010 48 Male 123 lb 12/24/2010 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/17/2010 44 Male 12/24/2010 Physician United States
Primary
Secondary
Vomiting Other Serious 12/20/2010 75 Male 159 lb 12/31/2010 Physician Colombia
Primary
Secondary
Concomitant
Chest Pain Hospitalization 11/3/2010 80 Male 242 lb 1/3/2011 Physician United States
Primary
Secondary
Coronary Artery Disease Hospitalization 7/14/2010 56 Male 272 lb 1/3/2011 Physician United States
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 12/3/2010 61 Male 168 lb 1/5/2011 Physician Colombia
Primary
Secondary
Concomitant
Brain Natriuretic Peptide Increased Other Serious 12/25/2010 66 Male 139 lb 1/6/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 12/11/2010 78 Male 157 lb 1/6/2011 Physician Italy
Primary
Secondary
Concomitant
Left Ventricular Dysfunction Hospitalization 11/2/2010 70 Male 196 lb 1/7/2011 Physician Netherlands
Primary
Secondary
Speech Disorder Hospitalization 12/25/2010 69 Female 150 lb 1/7/2011 Physician Lithuania
Primary
Secondary
Joint Swelling Hospitalization 7/22/2010 79 Male 108 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Chest Pain Hospitalization 11/3/2010 80 Male 242 lb 1/8/2011 Physician United States
Primary
Secondary
Infarction Death Male 170 lb 1/13/2011 Physician Brazil
Primary
Secondary
Renal Failure Chronic Life Threatening 1/9/2011 77 Male 191 lb 1/13/2011 Physician Spain
Primary
Secondary
Concomitant
Infarction Death Male 170 lb 1/16/2011 Physician Brazil
Primary
Secondary
Fluid Overload Hospitalization 12/13/2009 90 Female 95 lb 1/17/2011 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Cholelithiasis Other Serious 7/22/2010 79 Male 108 lb 1/18/2011 Physician Japan
Primary
Secondary
Concomitant
Polyuria Hospitalization 12/18/2010 66 Male 139 lb 1/19/2011 Physician Japan
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 12/1/2010 38 Male 170 lb 1/19/2011 Physician France
Primary
Secondary
Concomitant
Arrhythmia Life Threatening 2/19/2010 51 Male 150 lb 1/20/2011 Physician Brazil
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 12/28/2010 77 Male 191 lb 1/20/2011 Physician Spain
Primary
Secondary
Concomitant
Diverticulitis Life Threatening 12/31/2010 77 Male 191 lb 1/21/2011 Physician Spain
Primary
Secondary
Concomitant
Nasopharyngitis Other Serious 1/8/2011 62 Female 132 lb 1/21/2011 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Other Serious 11/25/2010 78 Male 157 lb 1/23/2011 Physician Italy
Primary
Secondary
Concomitant
Ankle Fracture Hospitalization 7/22/2010 79 Male 108 lb 1/25/2011 Physician Japan
Primary
Secondary
Concomitant
Atrial Flutter Hospitalization 7/14/2010 56 Male 272 lb 1/25/2011 Physician United States
Primary
Secondary
Concomitant
Electrolyte Imbalance Hospitalization 12/20/2010 75 Male 159 lb 1/25/2011 Physician Colombia
Primary
Secondary
Concomitant
Colonic Polyp Hospitalization 12/7/2010 75 Male 139 lb 1/26/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Cardiac Failure Acute Hospitalization 1/10/2011 70 Female 190 lb 1/26/2011 Physician Italy
Primary
Secondary
Concomitant
Overdose Other Serious 12/21/2010 71 Male 227 lb 1/26/2011 Physician Denmark
Primary
Secondary
Angina Unstable Hospitalization 1/6/2011 70 Male 251 lb 1/26/2011 Physician Latvia
Primary
Secondary
Abdominal Pain Hospitalization 7/22/2010 79 Male 108 lb 1/27/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 1/19/2011 72 Male 1/31/2011 Physician United Kingdom
Primary
Secondary
Nocturnal Dyspnoea Hospitalization 3/9/2010 49 Male 152 lb 2/1/2011 Physician Japan
Primary
Secondary
Concomitant
Condition Aggravated Other Serious 12/31/2010 77 Male 191 lb 2/1/2011 Physician Spain
Primary
Secondary
Concomitant
Bile Duct Obstruction Hospitalization 12/12/2010 53 Female 170 lb 2/1/2011 Physician Argentina
Primary
Secondary
Concomitant
Orthostatic Hypotension Hospitalization 11/11/2010 76 Male 132 lb 2/1/2011 Physician Italy
Primary
Secondary
Concomitant
Dyspnoea Other Serious 12/1/2010 62 Male 2/2/2011 Physician Japan
Primary
Secondary
Concomitant
Cough Hospitalization 6/22/2010 50 Male 136 lb 2/2/2011 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 1/24/2011 72 Male 2/4/2011 Physician United Kingdom
Primary
Secondary
Speech Disorder Hospitalization 12/25/2010 69 Female 150 lb 2/4/2011 Physician Lithuania
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 1/19/2011 72 Male 2/4/2011 Physician United Kingdom
Primary
Secondary
Influenza Like Illness Life Threatening 1/20/2011 58 Male 205 lb 2/4/2011 Physician Germany
Primary
Secondary
Eyelid Oedema Other Serious 7/22/2010 79 Male 108 lb 2/4/2011 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 3/2/2010 82 Male 195 lb 2/4/2011 Physician Argentina
Primary
Secondary
Concomitant
Catheterisation Cardiac Hospitalization 7/14/2010 56 Male 272 lb 2/7/2011 Physician United States
Primary
Secondary
Concomitant
Hyperglycaemia Other Serious 1/10/2011 70 Female 190 lb 2/9/2011 Physician Italy
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 10/1/2010 75 Male 181 lb 2/9/2011 Physician Germany
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 3/9/2010 49 Male 152 lb 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Abdominal Pain Hospitalization 1/28/2011 78 Male 132 lb 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/23/2010 63 Female 83 lb 2/10/2011 Physician Thailand
Primary
Secondary
Abdominal Pain Hospitalization 1/29/2011 59 Male 224 lb 2/14/2011 Physician United States
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 7/1/2010 62 Male 223 lb 2/14/2011 Physician Brazil
Primary
Secondary
Concomitant
Medication Error 12/21/2010 71 Male 227 lb 2/15/2011 Physician Denmark
Primary
Secondary
Concomitant Disease Progression Hospitalization 12/12/2010 53 Female 170 lb 2/15/2011 Physician Argentina
Primary
Secondary
Concomitant
Dizziness Hospitalization 10/23/2010 76 Male 184 lb 2/16/2011 Physician Sweden
Primary
Secondary
Resuscitation Other Serious 6/7/2010 60 Male 153 lb 2/16/2011 Physician Brazil
Primary
Secondary
Concomitant
Death Death 2/5/2011 75 Male 209 lb 2/16/2011 Physician Italy
Primary
Secondary
Concomitant
International Normalised Ratio Decreased Hospitalization 1/28/2011 78 Male 132 lb 2/18/2011 Physician Japan
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 1/24/2011 72 Male 2/18/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Bone Atrophy Hospitalization 7/22/2010 79 Male 108 lb 2/18/2011 Physician Japan
Primary
Secondary
Concomitant
Myoplasty Death 11/1/2010 66 Male 133 lb 2/18/2011 Physician China
Primary
Secondary
Drug Ineffective Hospitalization 10/13/2010 75 Male 207 lb 2/18/2011 Physician Germany
Primary
Secondary
Concomitant
Hypertension Other Serious 11/15/2010 Male 163 lb 2/21/2011 Physician Argentina
Primary
Secondary
Blood Potassium Increased Hospitalization 7/14/2010 56 Male 272 lb 2/21/2011 Physician United States
Primary
Secondary
Concomitant
Pulmonary Oedema Hospitalization 8/20/2010 65 Male 247 lb 2/23/2011 Physician Czech Republic
Primary
Secondary
Hypotension Hospitalization 4/2/2010 58 Male 154 lb 2/23/2011 Physician Belgium
Primary
Secondary
Concomitant
Bladder Operation Hospitalization 10/1/2010 75 Male 181 lb 2/24/2011 Physician Germany
Primary
Secondary
Concomitant
Vertigo Hospitalization 2/20/2004 61 Male 165 lb 2/24/2011 Physician Czech Republic
Primary
Secondary
Coronary Artery Disease Hospitalization 1/6/2011 70 Male 229 lb 2/24/2011 Physician Latvia
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization 6/7/2010 60 Male 153 lb 2/25/2011 Physician Brazil
Primary
Secondary
Concomitant
Asthma Hospitalization 8/20/2010 65 Male 247 lb 2/25/2011 Physician Czech Republic
Primary
Secondary
Fatigue Hospitalization 8/21/2010 68 Male 161 lb 2/25/2011 Physician China
Primary
Secondary
Diabetic Nephropathy Hospitalization 2/15/2011 70 Male 165 lb 2/25/2011 Physician China
Primary
Secondary
Arrhythmia Hospitalization 11/12/2010 71 Male 172 lb 2/28/2011 Physician China
Primary
Secondary
Coronary Artery Stenosis Hospitalization 4/25/2010 75 Male 199 lb 3/2/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Coronary Arterial Stent Insertion Hospitalization 12/22/2010 38 Male 170 lb 3/3/2011 Physician France
Primary
Secondary
Concomitant
Renal Impairment Other Serious 1/28/2011 78 Male 132 lb 3/3/2011 Physician Japan
Primary
Secondary
Concomitant
Dizziness Hospitalization 3/3/2010 71 Male 229 lb 3/3/2011 Physician Ireland
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Death Male 185 lb 3/4/2011 Physician Brazil
Primary
Secondary
Concomitant
Cardiac Failure Other Serious 12/1/2010 62 Male 3/4/2011 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 8/13/2010 60 Male 225 lb 3/4/2011 Physician United States
Primary
Secondary
Concomitant
Pulmonary Oedema Hospitalization 8/20/2010 65 Male 247 lb 3/6/2011 Physician Czech Republic
Primary
Secondary
Hernia Repair Other Serious 4/25/2010 75 Male 199 lb 3/7/2011 Physician Germany
Primary
Secondary
Concomitant
Death Death 2/5/2011 75 Male 209 lb 3/7/2011 Physician Italy
Primary
Secondary
Concomitant
Diverticulitis Other Serious 3/17/2010 67 Male 155 lb 3/6/2011 Physician France
Primary
Secondary
Oedema Hospitalization 1/24/2011 72 Male 3/8/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 10/15/2010 39 Male 298 lb 3/10/2011 Physician Germany
Primary
Secondary
Hyperglycaemia Hospitalization 2/26/2011 56 Male 3/10/2011 Physician United States
Primary
Secondary
Pneumonia Hospitalization 4/25/2010 75 Male 199 lb 3/10/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Hypotension Hospitalization 10/25/2010 66 Male 172 lb 3/11/2011 Physician Spain
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 2/1/2011 3/14/2011 Physician Japan
Primary
Secondary
Concomitant
Asthenia Other Serious 1/28/2011 78 Male 132 lb 3/14/2011 Physician Japan
Primary
Secondary
Concomitant
Dyspnoea Other Serious 3/3/2010 71 Male 229 lb 3/14/2011 Physician Ireland
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization 11/12/2010 71 Male 172 lb 3/15/2011 Physician China
Primary
Secondary
Gout Other Serious 1/28/2011 70 Male 165 lb 3/16/2011 Physician China
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 2/10/2011 65 Female 137 lb 3/24/2011 Physician Colombia
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 1/28/2011 78 Male 132 lb 3/25/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Potassium Increased Hospitalization 7/14/2010 56 Male 272 lb 3/25/2011 Physician United States
Primary
Secondary
Concomitant
Atrial Flutter Hospitalization 2/1/2011 3/25/2011 Physician Japan
Primary
Secondary
Concomitant
Abdominal Pain Other Serious 3/3/2011 78 Male 203 lb 3/25/2011 Physician Ireland
Primary
Secondary
Concomitant
Haematuria Hospitalization 10/24/2010 82 Male 121 lb 3/28/2011 Physician Peru
Primary
Secondary
Concomitant
Cardiac Pacemaker Insertion Hospitalization 12/3/2010 61 Male 168 lb 3/28/2011 Physician Colombia
Primary
Secondary
Concomitant
Ventricular Fibrillation Hospitalization 3/23/2011 66 Male 181 lb 3/30/2011 Physician Poland
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
Breath Sounds Abnormal Other Serious 12/13/2009 90 Female 95 lb 4/4/2011 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Renal Failure Other Serious 3/19/2011 66 Male 159 lb 4/5/2011 Physician Greece
Primary
Secondary
Concomitant
Dehydration Hospitalization 1/28/2011 78 Male 132 lb 4/5/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 10/13/2010 75 Male 207 lb 4/5/2011 Physician Germany
Primary
Secondary
Concomitant
Accidental Overdose Hospitalization 4/2/2010 58 Male 154 lb 4/5/2011 Physician Belgium
Primary
Secondary
Concomitant
Acute Pulmonary Oedema Hospitalization 3/26/2011 77 Male 132 lb 4/11/2011 Physician Italy
Primary
Secondary
Asthma Hospitalization 8/21/2010 68 Male 161 lb 4/13/2011 Physician China
Primary
Secondary
Myocardial Ischaemia Hospitalization 6/14/2010 62 Male 4/15/2011 Physician Japan
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 7/14/2010 56 Male 272 lb 4/15/2011 Physician United States
Primary
Secondary
Concomitant
Chest Discomfort Hospitalization 12/1/2010 62 Male 4/15/2011 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 2/1/2011 4/17/2011 Physician Japan
Primary
Secondary
Concomitant
Cholangitis Other Serious 1/28/2011 78 Male 132 lb 4/18/2011 Physician Japan
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 3/26/2011 77 Male 132 lb 4/18/2011 Physician Italy
Primary
Secondary
Chest Discomfort Hospitalization 12/1/2010 62 Male 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Abdominal Pain Hospitalization 10/7/2010 53 Female 159 lb 4/20/2011 Physician Venezuela
Primary
Secondary
Concomitant
Abdominal Pain Other Serious 3/3/2011 78 Male 203 lb 4/17/2011 Physician Ireland
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/13/2011 44 Male 586 lb 4/22/2011 Physician
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization Male 196 lb 4/25/2011 Physician Netherlands
Primary
Secondary
Condition Aggravated Hospitalization 1/18/2011 27 Male 267 lb 4/25/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Cardiac Arrest Hospitalization 4/7/2011 63 Male 218 lb 4/27/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 10/17/2010 44 Male 4/15/2011 Physician United States
Primary
Secondary
Cardiac Failure Chronic Life Threatening 11/29/2010 58 Male 188 lb 4/29/2011 Physician Germany
Primary
Secondary
Concomitant
Hypotension Hospitalization 12/20/2010 75 Male 159 lb 4/29/2011 Physician Colombia
Primary
Secondary
Concomitant
Bronchitis Hospitalization 2/3/2011 75 Female 159 lb 5/5/2011 Physician United States
Primary
Secondary
Concomitant
Acute Pulmonary Oedema Hospitalization 3/26/2011 77 Male 132 lb 5/5/2011 Physician Italy
Primary
Secondary
Asthenia Hospitalization 1/28/2011 78 Male 132 lb 5/9/2011 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 8/21/2010 68 Male 161 lb 5/12/2011 Physician China
Primary
Secondary
Dehydration Hospitalization 4/1/2011 44 Male 267 lb 5/15/2011 Physician United States
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Hospitalization 12/1/2010 62 Male 5/16/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Pulmonary Oedema Hospitalization 3/26/2011 77 Male 132 lb 5/16/2011 Physician Italy
Primary
Secondary
Loss Of Consciousness Other Serious 12/1/2010 62 Male 5/18/2011 Physician Japan
Primary
Secondary
Concomitant
Hyperglycaemia Hospitalization 8/21/2010 71 Female 159 lb 5/18/2011 Physician Germany
Primary
Secondary
Cardiomegaly Hospitalization 8/21/2010 68 Male 161 lb 5/23/2011 Physician China
Primary
Secondary
Concomitant
Death Hospitalization 5/20/2011 78 Male 181 lb 5/24/2011 Physician Italy
Primary
Secondary
Ventricular Tachycardia Hospitalization 4/4/2011 63 Male 159 lb 5/27/2011 Physician Japan
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 5/20/2011 78 Male 181 lb 6/3/2011 Physician Italy
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 4/4/2011 63 Male 159 lb 6/3/2011 Physician Japan
Primary
Secondary
Concomitant
Chest Discomfort Other Serious 12/1/2010 62 Male 6/6/2011 Physician Japan
Primary
Secondary
Concomitant
Tachycardia Hospitalization 3/12/2010 66 Male 174 lb 6/12/2011 Physician Austria
Primary
Secondary
Bradycardia Hospitalization 3/26/2011 64 Female 226 lb 6/14/2011 Physician United States
Primary
Secondary
Concomitant
Pulmonary Congestion Hospitalization 6/11/2011 69 Male 163 lb 6/27/2011 Physician Japan
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 8/21/2010 68 Male 161 lb 6/28/2011 Physician China
Primary
Secondary
Concomitant
Syncope Other Serious 5/21/2011 91 Male 218 lb 6/29/2011 Physician Ireland
Primary
Secondary
Concomitant
Concomitant Disease Progression Other Serious 3/22/2011 59 Male 205 lb 6/30/2011 Physician Denmark
Primary
Secondary
Concomitant

Drug Data