Lantus combined with Placebo

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Coronary Arterial Stent Insertion Hospitalization 1/29/2007 Male 162 lb 3/5/2007 Physician United States
Primary
Secondary
Concomitant
Coronary Arterial Stent Insertion Hospitalization 1/29/2007 Male 162 lb 3/26/2007 Physician United States
Primary
Secondary
Concomitant
Pancreatic Insufficiency Life Threatening 6/5/2006 Male 110 lb 3/26/2007 Physician France
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 1/1/2005 62 Male 126 lb 2/11/2008 Physician United States
Primary
Concomitant
Pancreatitis Acute Hospitalization 8/28/2005 62 Male 126 lb 2/28/2008 Physician United States
Primary
Concomitant
Pancreatic Insufficiency Life Threatening 6/5/2006 Male 110 lb 7/18/2008 Physician France
Primary
Secondary
Concomitant
Pancreatic Insufficiency Life Threatening 6/5/2006 Male 110 lb 7/24/2008 Physician France
Primary
Secondary
Concomitant
Steatorrhoea Life Threatening 6/5/2006 Male 110 lb 8/19/2008 Physician France
Primary
Secondary
Concomitant
Pyrexia Hospitalization 11/28/2008 64 Male 2/20/2009 Consumer United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 11/28/2008 64 Male 2/26/2009 Consumer United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 11/28/2008 64 Male 3/4/2009 Consumer United States
Primary
Secondary
Concomitant
Generalised Oedema Hospitalization 6/23/2009 Female 316 lb 7/21/2009 Physician United States
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 7/24/2009 Physician United States
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 7/31/2009 Physician United States
Primary
Secondary
Concomitant
Diverticulitis Hospitalization 8/7/2009 Female 168 lb 9/11/2009 Physician Finland
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 9/25/2009 Physician United States
Primary
Secondary
Concomitant
Breast Abscess Hospitalization 6/15/2009 Female 192 lb 10/28/2009 Physician Australia
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 11/6/2009 Physician United States
Primary
Secondary
Concomitant
Breast Abscess Hospitalization 6/15/2009 Female 192 lb 11/17/2009 Physician Australia
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 8/28/2005 62 Male 126 lb 11/30/2009 Physician United States
Primary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 12/23/2009 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 6/15/2009 Female 192 lb 1/21/2010 Physician Australia
Primary
Secondary
Concomitant
Vomiting Other Serious 2/10/2009 Female 3/2/2010 Physician
Primary
Secondary
Concomitant
Abscess Neck Hospitalization 2/28/2010 Female 194 lb 3/12/2010 Physician Australia
Primary
Secondary
Concomitant
Abscess Neck Hospitalization 2/28/2010 Female 194 lb 3/19/2010 Physician Australia
Primary
Secondary
Concomitant
Lymphadenopathy Other Serious 2/28/2010 36 Male 7/8/2010 Physician Canada
Primary
Secondary
Concomitant
Lymphadenopathy Other Serious 2/28/2010 36 Male 8/6/2010 Physician Canada
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 4/13/2010 72 Female 185 lb 8/10/2010 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 4/13/2010 72 Female 185 lb 9/20/2010 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 9/24/2010 67 Male 10/10/2010 Other Health Professional Australia
Primary
Secondary
Concomitant
Vomiting Other Serious 8/1/2010 67 Male 231 lb 10/22/2010 Physician Australia
Primary
Secondary
Concomitant
Pneumonia Life Threatening 9/1/2010 78 Male 194 lb 11/3/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Lymphadenopathy Hospitalization 2/28/2010 36 Male 11/5/2010 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Life Threatening 9/28/2010 78 Male 194 lb 11/10/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Coronary Artery Disease Life Threatening 8/30/2010 67 Male 11/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 2/28/2010 28 Female 194 lb 11/23/2010 Physician Australia
Primary
Secondary
Concomitant
Pancreatitis Other Serious 11/5/2010 80 Female 11/26/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Life Threatening 9/22/2010 71 Female 12/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 2/28/2010 36 Male 229 lb 12/13/2010 Physician Canada
Primary
Secondary
Concomitant
Acute Myocardial Infarction Life Threatening 8/22/2009 73 Male 141 lb 12/16/2010 Physician Israel
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 11/25/2010 51 Male 12/20/2010 Consumer United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 8/26/2010 69 Male 12/6/2010 Physician Canada
Primary
Secondary
Concomitant
Lymphadenopathy Hospitalization 2/28/2010 36 Male 229 lb 12/28/2010 Physician Canada
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 9/24/2010 67 Male 12/30/2010 Other Health Professional Australia
Primary
Secondary
Concomitant
Acute Myocardial Infarction Hospitalization 12/23/2010 58 Male 147 lb 1/4/2011 Physician India
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 11/25/2010 51 Male 1/5/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 11/30/2010 60 Female 1/7/2011 Other Health Professional United States
Primary
Secondary
Vomiting Hospitalization 9/22/2010 71 Female 1/9/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Lactic Acidosis Hospitalization 1/1/2010 67 Male 255 lb 1/12/2011 Physician Australia
Primary
Secondary
Concomitant
Blood Creatinine Increased Other Serious 11/5/2010 80 Female 1/12/2011 Consumer United States
Primary
Secondary
Concomitant
Acute Myocardial Infarction Hospitalization 12/23/2010 58 Male 147 lb 1/13/2011 Physician India
Primary
Secondary
Concomitant
Acute Myocardial Infarction Hospitalization 8/26/2010 69 Male 1/4/2011 Physician Canada
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 1/1/2010 67 Male 255 lb 1/14/2011 Consumer Australia
Primary
Secondary
Concomitant
Hypoglycaemic Seizure Hospitalization 12/21/2010 61 Male 1/27/2011 Consumer Germany
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 2/5/2011 3/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Myalgia Other Serious 8/13/2010 47 Male 3/30/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Arrhythmia Death 1/7/2011 79 Male 4/7/2011 Physician Netherlands
Primary
Concomitant
Pancreatitis Other Serious 4/6/2011 68 Male 5/9/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 4/6/2011 68 Male 5/12/2011 Consumer United States
Primary
Secondary
Concomitant
Endometrial Cancer Other Serious 6/25/2010 56 Female 5/6/2011 Israel
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 4/6/2011 68 Male 5/18/2011 Consumer United States
Primary
Secondary
Concomitant
Brain Stem Infarction Hospitalization 1/27/2010 44 Female 201 lb 5/30/2011 Physician United States
Primary
Secondary
Concomitant
Hypertriglyceridaemia Other Serious 5/25/2011 41 Female 274 lb 6/3/2011 Physician United States
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 4/6/2011 68 Male 6/7/2011 Consumer United States
Primary
Secondary
Concomitant
Hypertriglyceridaemia Other Serious 4/21/2011 41 Female 273 lb 6/9/2011 Physician United States
Primary
Secondary
Concomitant
Intra-abdominal Haemorrhage Other Serious 4/11/2008 51 Male 185 lb 6/13/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Bradycardia Hospitalization 3/26/2011 64 Female 226 lb 6/14/2011 Physician United States
Primary
Secondary
Concomitant
Medication Error Other Serious 4/21/2011 41 Female 273 lb 6/16/2011 Physician United States
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 2/14/2011 52 Male 203 lb 6/21/2011 Physician United States
Primary
Secondary
Concomitant
Chest Discomfort Hospitalization 5/26/2011 76 Male 6/24/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 6/6/2011 63 Male 7/6/2011 Consumer Germany
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 6/6/2011 63 Male 7/8/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Febrile Neutropenia Death 4/4/2009 73 Female 146 lb 7/12/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Brain Stem Infarction Hospitalization 1/27/2010 44 Female 201 lb 7/14/2011 Physician United States
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 6/5/2011 63 Male 7/14/2011 Other Health Professional Italy
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 5/6/2011 80 Female 157 lb 7/18/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 7/5/2011 68 Male 7/20/2011 Consumer United States
Primary
Secondary
Abdominal Pain Other Serious 2/2/2011 65 Female 7/25/2011 Consumer Italy
Primary
Concomitant
Fall Hospitalization 4/9/2011 62 Male 7/25/2011 Physician Sweden
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 7/5/2011 68 Male 7/26/2011 Consumer United States
Primary
Secondary
Renal Failure Acute Life Threatening 7/3/2011 82 Female 8/3/2011 Consumer United States
Primary
Secondary
Concomitant
Lactic Acidosis Hospitalization 7/5/2011 68 Male 8/4/2011 Consumer United States
Primary
Secondary
Urosepsis Hospitalization 7/3/2011 82 Female 8/5/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Lactic Acidosis Hospitalization 7/5/2011 68 Male 8/10/2011 Physician Czech Republic
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/3/2011 82 Female 8/11/2011 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 6/29/2008 70 Female 8/12/2011 Physician United States
Primary
Secondary
Concomitant
Presyncope Hospitalization 6/19/2011 66 Male 8/17/2011 Physician United States
Primary
Secondary
Concomitant
Asthma Other Serious 2/2/2011 65 Female 8/17/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 2/24/2011 66 Female 8/19/2011 Physician United States
Primary
Secondary
Concomitant
Haematuria Hospitalization 6/14/2011 76 Male 8/12/2011 Consumer United States
Primary
Secondary
Concomitant
Blood Culture Positive Hospitalization 7/3/2011 82 Female 8/17/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Syncope Other Serious 7/3/2011 82 Female 8/17/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Cardiac Failure Other Serious 2/4/2010 72 Male 211 lb 8/19/2011 United States
Primary
Secondary
Concomitant
Chest Pain Hospitalization 2/2/2011 65 Female 8/31/2011 Consumer Italy
Primary
Concomitant
Gastroenteritis Hospitalization 7/5/2011 68 Male 9/9/2011 Physician Czech Republic
Primary
Secondary
Concomitant
Appendicitis Hospitalization 4/11/2011 43 Male 171 lb 9/12/2011 Physician United States
Primary
Secondary
Concomitant
Appendicitis Hospitalization 4/4/2011 43 Male 171 lb 9/19/2011 Physician United States
Primary
Secondary
Concomitant
Transitional Cell Carcinoma Life Threatening 6/17/2010 70 Female 9/19/2011 Physician Norway
Primary
Secondary
Concomitant
Diabetic Ketoacidosis Hospitalization 4/4/2011 43 Male 171 lb 9/26/2011 Physician United States
Primary
Secondary
Concomitant
Ankle Fracture Hospitalization 8/31/2011 77 Male 10/5/2011 Physician United States
Primary
Secondary
Concomitant
Colonic Polyp Hospitalization 9/5/2011 73 Female 181 lb 10/5/2011 Physician Japan
Primary
Secondary
Concomitant
Hypotension Death 1/7/2011 79 Male 10/26/2011 Physician Netherlands
Primary
Concomitant
Lymphoid Tissue Hyperplasia Hospitalization 2/28/2010 36 Male 229 lb 10/27/2011 Physician Canada
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 2/5/2011 11/15/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 1/15/2011 79 Male 11/18/2011 Physician Netherlands
Primary
Concomitant
Diabetic Ketoacidosis Other Serious 4/4/2011 43 Male 171 lb 11/18/2011 Physician United States
Primary
Secondary
Concomitant
Pancreatitis Other Serious 9/25/2011 73 Female 11/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 1/15/2011 79 Male 11/22/2011 Physician Netherlands
Primary
Concomitant
Cardiac Tamponade Hospitalization 8/8/2011 75 Male 11/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Syncope Hospitalization 11/3/2011 58 Male 11/23/2011 Physician United States
Primary
Secondary
Concomitant
Colonic Polyp Hospitalization 9/5/2011 73 Female 181 lb 11/27/2011 Physician Japan
Primary
Secondary
Concomitant
Urosepsis Hospitalization 7/3/2011 82 Female 12/14/2011 Consumer United States
Primary
Secondary
Concomitant
Abdominal Pain Upper Hospitalization 9/22/2010 71 Female 12/14/2011 Consumer United States
Primary
Secondary
Concomitant
Ankle Fracture Hospitalization 8/31/2011 77 Male 12/20/2011 Physician United States
Primary
Secondary
Concomitant
Anaemia Other Serious 11/3/2011 70 Female 1/4/2012 Physician Japan
Primary
Secondary
Concomitant
Tachycardia Hospitalization 10/12/2011 77 Male 1/5/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 5/6/2011 80 Female 157 lb 1/6/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Post Procedural Haemorrhage Other Serious 11/3/2011 70 Female 1/10/2012 Physician Japan
Primary
Secondary
Concomitant
Hypoxia Hospitalization 2/5/2010 44 Male 1/18/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Chest Pain Other Serious 12/30/2011 56 Male 236 lb 1/27/2012 Physician Australia
Primary
Secondary
Concomitant
Prostate Cancer Hospitalization 8/18/2011 66 Male 222 lb 2/6/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 9/24/2010 67 Male 2/14/2012 Other Health Professional Australia
Primary
Secondary
Concomitant
Abdominal Distension Hospitalization 1/1/2011 61 Male 2/16/2012 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 9/24/2010 67 Male 255 lb 2/28/2012 Consumer Australia
Primary
Secondary
Concomitant
Fall Hospitalization 5/26/2011 76 Male 2/29/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Erythema Hospitalization 6/4/2011 82 Male 3/7/2012 Consumer United States
Primary
Secondary
Concomitant
Syncope Hospitalization 11/3/2011 65 Male 3/9/2012 Physician United States
Primary
Secondary
Concomitant
Gastrointestinal Telangiectasia Hospitalization 7/6/2011 75 Female 3/13/2012 Consumer United States
Primary
Secondary
Septic Shock Other Serious 12/22/2011 65 Male 154 lb 3/14/2012 Physician France
Primary
Secondary
Concomitant
Syncope Hospitalization 11/3/2011 58 Male 3/27/2012 Physician United States
Primary
Secondary
Concomitant
Hypoglycaemic Seizure Hospitalization 3/12/2012 64 Male 3/28/2012 Consumer Argentina
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 4/4/2011 43 Male 171 lb 3/29/2012 Physician United States
Primary
Secondary
Concomitant
Septic Shock Other Serious 12/22/2011 65 Male 154 lb 4/5/2012 Physician France
Primary
Secondary
Concomitant
Familial Hypocalciuric Hypercalcaemia Hospitalization 3/23/2012 73 Female 193 lb 4/16/2012 Other Health Professional Canada
Primary
Secondary
Concomitant
Unevaluable Event Hospitalization 12/24/2011 62 Female 4/25/2012 Consumer United States
Primary
Secondary
Interacting
Hepatic Neoplasm Other Serious 12/24/2011 62 Female 4/26/2012 Physician Canada
Primary
Secondary
Concomitant
Hypoglycaemic Seizure Hospitalization 3/12/2012 64 Male 4/30/2012 Other Health Professional Argentina
Primary
Secondary
Concomitant
Hypoglycaemic Seizure Hospitalization 3/12/2012 64 Male 5/3/2012 Consumer Argentina
Primary
Secondary
Concomitant
Tuberculous Pleurisy Other Serious 6/4/2011 82 Male 5/7/2012 Consumer United States
Primary
Secondary
Concomitant
Circulatory Collapse Hospitalization 1/7/2011 79 Male 5/9/2012 Physician Netherlands
Primary
Concomitant
Fluid Overload Hospitalization 7/3/2011 82 Female 5/10/2012 Consumer United States
Primary
Secondary
Concomitant
Angina Pectoris Hospitalization 11/3/2011 65 Male 5/15/2012 Physician United States
Primary
Secondary
Concomitant
Urosepsis Hospitalization 7/3/2011 82 Female 5/15/2012 Consumer United States
Primary
Secondary
Concomitant
Burns Second Degree Life Threatening 3/31/2012 62 Male 5/15/2012 Physician United States
Primary
Secondary
Concomitant
Colonic Polyp Hospitalization 9/5/2011 73 Female 181 lb 5/16/2012 Physician Japan
Primary
Secondary
Concomitant
Hepatic Neoplasm Hospitalization 12/24/2011 62 Female 5/22/2012 Physician Canada
Primary
Secondary
Concomitant
Orthostatic Hypotension Hospitalization 3/17/2012 80 Male 5/29/2012 Consumer United States
Primary
Secondary
Hepatic Neoplasm Other Serious 12/24/2011 62 Female 6/6/2012 Physician Canada
Primary
Secondary
Concomitant
Cardiac Arrest Death 5/3/2011 57 Male 163 lb 6/9/2012 Physician Belgium
Primary
Secondary
Concomitant
Hyperkalaemia Other Serious 8/17/2011 59 Male 181 lb 6/11/2012 Physician France
Primary
Secondary
Concomitant

Drug Data