Blinded NO Treatment Received Nomed combined with Blinded Placebo Comp-Pla+

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Urine Output Decreased Other Serious 5/13/2008 Female 5/29/2008 Physician Taiwan, Province Of China
Primary
Secondary
Pyrexia Other Serious 5/22/2008 Male 6/5/2008 Physician Spain
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Hospitalization 5/9/2008 Male 185 lb 6/24/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Aphthous Stomatitis Disability 6/10/2008 Female 121 lb 6/24/2008 Physician Turkey
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 5/13/2008 Female 6/26/2008 Physician Taiwan, Province Of China
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Life Threatening 5/9/2008 Male 185 lb 6/30/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 6/10/2008 Female 121 lb 7/11/2008 Physician Turkey
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 11/1/2007 Male 170 lb 7/16/2008 Physician United States
Primary
Secondary
Concomitant
Pyrexia Death Male 7/31/2008 Consumer United States
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Other Serious 4/11/2008 Male 185 lb 7/28/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Skin Infection Hospitalization Female 126 lb 8/5/2008 Physician Israel
Primary
Secondary
Hypomagnesaemia Hospitalization 7/22/2008 Female 223 lb 7/29/2008 Physician Australia
Primary
Secondary
Myocardial Infarction Other Serious 6/30/2008 Female 120 lb 8/12/2008 Physician United States
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 6/30/2008 Female 120 lb 8/12/2008 Physician United States
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 6/30/2008 Female 120 lb 8/15/2008 Physician United States
Primary
Secondary
Concomitant
Hypomagnesaemia Hospitalization 7/22/2008 Female 223 lb 8/14/2008 Physician Australia
Primary
Secondary
Skin Infection Hospitalization 7/26/2008 Female 126 lb 8/20/2008 Physician Israel
Primary
Secondary
Thrombotic Thrombocytopenic Purpura Other Serious 4/11/2008 Male 185 lb 8/22/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Heat Illness Other Serious 8/10/2008 Male 137 lb 8/26/2008 Physician Japan
Primary
Secondary
Muscle Twitching Other Serious 6/30/2008 Female 120 lb 8/28/2008 Physician United States
Primary
Secondary
Concomitant
Pollakiuria Hospitalization 7/27/2007 Female 108 lb 9/11/2008 Physician United States
Primary
Secondary
Concomitant
Mycobacterium Avium Complex Infection Other Serious 7/24/2008 Female 134 lb 9/16/2008 Other Health Professional United States
Primary
Secondary
Tumour Necrosis Hospitalization 8/29/2008 Female 9/19/2008 Physician Netherlands
Primary
Secondary
Muscle Twitching Other Serious 6/30/2008 Female 120 lb 9/23/2008 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 9/15/2008 Female 146 lb 10/2/2008 United States
Primary
Secondary
Weight Decreased Hospitalization 9/2/2008 Female 97 lb 10/7/2008 Physician France
Primary
Secondary
Ureteral Stent Removal Hospitalization 7/14/2008 Female 159 lb 10/10/2008 Physician Germany
Primary
Secondary
Concomitant
Muscle Twitching Other Serious 6/30/2008 Female 120 lb 10/15/2008 Physician United States
Primary
Secondary
Concomitant
Tumour Necrosis Hospitalization 8/29/2008 Female 10/15/2008 Physician Netherlands
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/24/2008 Female 134 lb 10/15/2008 Other Health Professional United States
Primary
Secondary
Tricuspid Valve Incompetence Hospitalization 3/9/2008 Female 118 lb 10/17/2008 Physician United States
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 10/1/2008 Female 161 lb 10/17/2008 Physician France
Primary
Secondary
Ureteral Stent Removal Hospitalization 7/14/2008 Female 159 lb 10/22/2008 Physician Germany
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 10/1/2008 Female 161 lb 11/7/2008 Physician France
Primary
Secondary
Tumour Necrosis Hospitalization 8/29/2008 Female 11/7/2008 Physician Netherlands
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 9/2/2008 Female 97 lb 11/13/2008 Physician France
Primary
Secondary
Pneumonia Hospitalization 11/11/2008 Female 11/20/2008 Physician United States
Primary
Secondary
Pneumonia Hospitalization 11/11/2008 Female 11/25/2008 Physician United States
Primary
Secondary
Vomiting Hospitalization 1/29/2008 Male 179 lb 12/4/2008 Physician Germany
Primary
Secondary
Staphylococcal Infection Hospitalization 10/20/2008 Male 12/4/2008 Physician France
Primary
Secondary
Concomitant
Hypotension Other Serious 5/3/2007 Male 182 lb 12/18/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Impaired Healing Other Serious 11/14/2008 Female 125 lb 12/29/2008 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 10/20/2008 Male 1/28/2009 Physician France
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 10/20/2008 Male 2/12/2009 Physician France
Primary
Secondary
Concomitant
Circulatory Collapse Hospitalization 1/8/2009 Male 247 lb 2/20/2009 Physician United States
Primary
Secondary
Concomitant
Renin-angiotensin System Inhibition Life Threatening 7/31/2008 Male 209 lb 3/4/2009 Other Health Professional Sweden
Primary
Secondary
Pyrexia Hospitalization 1/16/2009 Female 150 lb 3/13/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Visual Field Defect Other Serious 1/7/2008 77 Male 187 lb 3/20/2009 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 10/20/2008 Male 4/9/2009 Physician France
Primary
Secondary
Concomitant
Visual Field Defect Hospitalization 1/7/2008 77 Male 187 lb 4/9/2009 Physician United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 1/16/2009 Female 150 lb 4/10/2009 Physician Czech Republic
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/19/2007 Female 126 lb 4/14/2009 Physician Germany
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 4/7/2009 Male 4/17/2009 Physician Netherlands
Primary
Secondary
Concomitant
Pyrexia Other Serious 5/22/2008 Male 4/17/2009 Physician Spain
Primary
Secondary
Concomitant
Performance Status Decreased Hospitalization 1/26/2008 Male 117 lb 4/27/2009 Physician Belgium
Primary
Secondary
Road Traffic Accident Hospitalization 3/30/2009 Female 194 lb 5/1/2009 Physician Germany
Primary
Secondary
Pyrexia Other Serious 5/22/2008 Male 5/5/2009 Physician Spain
Primary
Secondary
Concomitant
Wheezing Hospitalization 4/8/2009 176 lb 5/15/2009 Physician United States
Primary
Secondary
Concomitant
Paraesthesia Other Serious Male 1735 lb 5/23/2009 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/19/2009 Female 136 lb 5/27/2009 Physician India
Primary
Secondary
Urine Output Decreased Hospitalization 4/21/2009 Male 217 lb 5/22/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Road Traffic Accident Hospitalization 3/30/2009 Female 194 lb 5/29/2009 Physician Germany
Primary
Secondary
Swelling Hospitalization 3/31/2009 Male 155 lb 6/2/2009 Physician United States
Primary
Secondary
White Blood Cell Count Increased Hospitalization 3/30/2009 Male 6/2/2009 Physician United States
Primary
Secondary
Concomitant
Vomiting Other Serious 3/2/2009 Female 171 lb 6/3/2009 Physician United States
Primary
Secondary
Vomiting Hospitalization 5/19/2009 Female 136 lb 6/11/2009 Physician India
Primary
Secondary
Arthritis Hospitalization 5/26/2009 Male 149 lb 6/17/2009 Physician Hong Kong
Primary
Secondary
Wheezing Hospitalization 4/8/2009 176 lb 6/25/2009 Physician United States
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 11/1/2007 Male 170 lb 6/26/2009 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 3/30/2009 Male 7/1/2009 Physician United States
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 4/22/2009 Male 217 lb 7/2/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Palindromic Rheumatism Hospitalization 5/26/2009 Male 149 lb 7/6/2009 Physician Hong Kong
Primary
Secondary
Swelling Hospitalization 3/31/2009 Male 155 lb 7/7/2009 Physician United States
Primary
Secondary
Pneumonitis Other Serious 1/7/2008 Female 136 lb 7/10/2009 Physician United States
Primary
Secondary
Concomitant
Vomiting Other Serious 3/2/2009 Female 171 lb 7/20/2009 Physician United States
Primary
Secondary
Vomiting Other Serious 3/2/2009 Female 171 lb 7/20/2009 Physician United States
Primary
Secondary
Pneumonitis Other Serious 5/31/2009 Male 150 lb 7/22/2009 Physician Germany
Primary
Secondary
Ventricular Extrasystoles Hospitalization 5/17/2009 Male 7/31/2009 Physician United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 8/13/2008 Female 90 lb 8/3/2009 Physician Japan
Primary
Secondary
Concomitant
Swelling Hospitalization 5/10/2009 Female 126 lb 8/5/2009 Physician United States
Primary
Secondary
Wound Infection Staphylococcal Hospitalization 3/31/2009 Female 206 lb 8/7/2009 Physician United States
Primary
Secondary
Tricuspid Valve Incompetence Hospitalization 3/9/2009 Male 212 lb 8/7/2009 Physician United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 3/17/2009 Female 134 lb 8/11/2009 Physician Japan
Primary
Secondary
Concomitant
Excoriation Hospitalization 7/22/2009 Male 157 lb 8/12/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonitis Other Serious 5/31/2009 Male 150 lb 8/12/2009 Physician Germany
Primary
Secondary
Ventricular Extrasystoles Hospitalization 5/17/2009 Male 8/13/2009 Physician United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 1/6/2009 Female 139 lb 8/13/2009 Physician United States
Primary
Secondary
Concomitant
Sputum Discoloured Hospitalization 6/26/2009 Male 175 lb 8/13/2009 Physician Korea, Republic Of
Primary
Secondary
Wheezing Other Serious 3/6/2009 Male 144 lb 8/18/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Death 7/5/2009 Male 121 lb 8/19/2009 Physician Japan
Primary
Secondary
Weight Decreased Other Serious 3/17/2009 Female 134 lb 8/20/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Death 7/5/2009 Male 121 lb 8/21/2009 Physician Japan
Primary
Secondary
Wound Drainage Hospitalization 5/11/2009 Male 238 lb 8/24/2009 Physician United States
Primary
Secondary
Renal Failure Hospitalization 8/19/2009 Male 190 lb 8/28/2009 Physician Germany
Primary
Secondary
Sputum Discoloured Hospitalization 6/26/2009 Male 175 lb 9/1/2009 Physician Korea, Republic Of
Primary
Secondary
Pneumonitis Other Serious 5/31/2009 Male 150 lb 9/3/2009 Physician Germany
Primary
Secondary
Periodontal Disease Other Serious 1/1/2009 Male 223 lb 9/8/2009 Physician United States
Primary
Secondary
Syncope Hospitalization 9/1/2009 Male 187 lb 9/9/2009 Physician Australia
Primary
Secondary
Concomitant
Respiratory Tract Infection Hospitalization 8/22/2009 Male 9/11/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Renal Failure Chronic Hospitalization 8/19/2009 Male 190 lb 9/11/2009 Physician Germany
Primary
Secondary
Respiratory Tract Infection Hospitalization 8/22/2009 Male 9/16/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Vomiting Other Serious 6/27/2009 Male 143 lb 9/18/2009 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/1/2009 Male 188 lb 9/23/2009 Physician United States
Primary
Secondary
Respiratory Tract Infection Hospitalization 8/22/2009 Male 9/24/2009 Physician Taiwan, Province Of China
Primary
Secondary
Concomitant
Ventricular Extrasystoles Hospitalization 5/17/2009 Male 9/28/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Death 7/5/2009 Male 121 lb 9/28/2009 Physician Japan
Primary
Secondary
Pyrexia Hospitalization 6/1/2009 Male 188 lb 9/30/2009 Physician United States
Primary
Secondary
Pneumonia Hospitalization 9/26/2009 Male 249 lb 10/2/2009 Physician United States
Primary
Secondary
Concomitant
Supraventricular Tachycardia Hospitalization 6/19/2009 Female 116 lb 10/5/2009 Physician United States
Primary
Secondary
Concomitant
Gastritis Erosive Hospitalization 4/15/2009 Female 121 lb 10/5/2009 Physician Germany
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 6/3/2009 Male 106 lb 10/5/2009 Physician Japan
Primary
Secondary
Concomitant
Syncope Hospitalization 9/1/2009 Male 187 lb 10/8/2009 Physician Australia
Primary
Secondary
Concomitant
Vomiting Other Serious 6/27/2009 Male 143 lb 10/13/2009 Physician Japan
Primary
Secondary
Concomitant
Unresponsive To Stimuli Hospitalization 9/8/2009 Female 258 lb 10/15/2009 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 6/3/2009 Male 106 lb 10/15/2009 Physician Japan
Primary
Secondary
Concomitant
Intestinal Perforation Death 10/15/2009 10/26/2009 Physician United States
Primary
Secondary
White Blood Cell Count Increased Other Serious 6/3/2009 Male 106 lb 10/26/2009 Physician Japan
Primary
Secondary
Concomitant
Intestinal Perforation Death 10/15/2009 10/28/2009 Physician United States
Primary
Secondary
Intestinal Perforation Death 10/15/2009 10/28/2009 Physician United States
Primary
Secondary
Supraventricular Tachycardia Hospitalization 6/19/2009 Female 116 lb 10/30/2009 Physician United States
Primary
Secondary
Concomitant
Gastritis Erosive Hospitalization 4/15/2009 Female 121 lb 10/30/2009 Physician Germany
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 9/2/2009 Female 353 lb 11/16/2009 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 6/3/2009 Male 106 lb 11/17/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/6/2009 Male 132 lb 11/23/2009 Physician Japan
Primary
Secondary
Concomitant
Gastritis Erosive Hospitalization 4/15/2009 Female 121 lb 11/23/2009 Physician Germany
Primary
Secondary
Concomitant
Vomiting Other Serious 11/6/2009 Male 132 lb 11/28/2009 Physician Japan
Primary
Secondary
Concomitant
Intestinal Perforation Death 10/15/2009 12/11/2009 Physician United States
Primary
Secondary
Haematuria Hospitalization 11/11/2009 Male 12/17/2009 Physician Netherlands
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 6/1/2009 Male 188 lb 12/18/2009 Physician United States
Primary
Secondary
Thrombocytopenia Hospitalization 10/23/2009 Male 194 lb 12/23/2009 Physician Germany
Primary
Secondary
Unresponsive To Stimuli Hospitalization 9/8/2009 Female 258 lb 12/29/2009 Physician United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 8/13/2008 Female 90 lb 1/5/2010 Physician Japan
Primary
Secondary
Concomitant
Haematuria Hospitalization 11/11/2009 Male 1/7/2010 Physician Netherlands
Primary
Secondary
Concomitant
Gastritis Erosive Hospitalization 4/15/2009 Female 121 lb 1/14/2010 Physician Germany
Primary
Secondary
Concomitant
Tachypnoea Other Serious 12/26/2009 Male 200 lb 1/15/2010 Physician United States
Primary
Secondary
Urinary Tract Infection Hospitalization 9/2/2009 Female 353 lb 1/22/2010 Physician United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 8/13/2008 Female 90 lb 2/1/2010 Physician Japan
Primary
Secondary
Concomitant
Presyncope Hospitalization 1/8/2009 Male 247 lb 2/7/2010 Physician United States
Primary
Secondary
Concomitant
Nausea Life Threatening 1/26/2010 Female 146 lb 2/7/2010 Physician United States
Primary
Secondary
Pyrexia Other Serious 8/13/2008 Female 90 lb 2/16/2010 Physician Japan
Primary
Secondary
Concomitant
Nausea Life Threatening 1/26/2010 Female 146 lb 2/17/2010 Physician United States
Primary
Secondary
Tachypnoea Other Serious 12/26/2009 Male 200 lb 2/24/2010 Physician United States
Primary
Secondary
Swelling Hospitalization 2/17/2010 Female 106 lb 2/24/2010 Physician Japan
Primary
Secondary
Concomitant
Nausea Life Threatening 1/26/2010 Female 146 lb 2/24/2010 Physician United States
Primary
Secondary
Influenza Like Illness Other Serious 12/14/2009 Female 222 lb 3/2/2010 Physician United States
Primary
Secondary
Concomitant
Tooth Extraction Hospitalization 12/29/2009 Female 106 lb 3/5/2010 Physician Japan
Primary
Secondary
Concomitant
Tachypnoea Other Serious 12/25/2009 Male 200 lb 3/8/2010 Physician United States
Primary
Secondary
White Blood Cell Count Increased Other Serious 11/19/2008 Male 149 lb 3/16/2010 Physician United States
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 3/4/2010 Female 115 lb 3/16/2010 Physician United States
Primary
Secondary
Subileus Other Serious 8/13/2008 Female 90 lb 3/16/2010 Physician Japan
Primary
Secondary
Concomitant

Drug Data