Golimumab combined with Placebo

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Intervertebral Discitis Hospitalization 3/23/2009 Female 159 lb 4/29/2009 Physician Argentina
Primary
Secondary
Concomitant
Gastrointestinal Neoplasm Hospitalization 3/2/2009 Female 157 lb 5/1/2009 Physician Argentina
Primary
Secondary
Concomitant
Uterine Haemorrhage Hospitalization 1/8/2009 Female 161 lb 5/6/2009 Physician Mexico
Primary
Secondary
Concomitant
Cellulitis Hospitalization 3/24/2009 Female 192 lb 5/6/2009 Physician Chile
Primary
Secondary
Concomitant
Bladder Cancer Other Serious 5/15/2008 Female 154 lb 5/6/2009 Physician Hungary
Primary
Secondary
Concomitant
Lymph Node Tuberculosis Other Serious 8/29/2008 Female 121 lb 5/14/2009 Physician Mexico
Primary
Secondary
Concomitant
Bladder Cancer Hospitalization 5/15/2008 Female 154 lb 5/14/2009 Physician Hungary
Primary
Secondary
Concomitant
Gastrointestinal Neoplasm Other Serious 3/2/2009 Female 157 lb 5/15/2009 Physician Argentina
Primary
Secondary
Concomitant
Adenocarcinoma Hospitalization 11/22/2008 Male 192 lb 5/15/2009 Physician Belgium
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/3/2009 Male 5/15/2009 Physician Australia
Primary
Secondary
Concomitant
Pneumonia Primary Atypical Hospitalization 5/5/2009 Female 112 lb 5/18/2009 Physician Germany
Primary
Secondary
Concomitant
Mycobacterium Kansasii Infection 8/1/2008 Male 152 lb 5/19/2009 Physician United States
Primary
Secondary
Concomitant
Abscess Limb Hospitalization 2/25/2009 Female 123 lb 5/19/2009 Physician Malaysia
Primary
Secondary
Concomitant
Abscess Limb Hospitalization 2/25/2009 Female 123 lb 5/19/2009 Physician Malaysia
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/10/2009 Male 176 lb 5/20/2009 Physician Australia
Primary
Secondary
Concomitant
Abscess Limb Hospitalization 2/25/2009 Female 123 lb 5/20/2009 Physician Malaysia
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 5/5/2009 Female 112 lb 5/21/2009 Physician Germany
Primary
Secondary
Concomitant
Sepsis Hospitalization 5/6/2009 Female 196 lb 5/22/2009 Physician United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 5/5/2009 Female 112 lb 5/27/2009 Physician Germany
Primary
Secondary
Concomitant
Rectal Cancer Other Serious 3/13/2009 Female 146 lb 5/29/2009 Physician United States
Primary
Secondary
Concomitant
Endometriosis Other Serious 4/14/2009 Female 157 lb 5/29/2009 Physician Argentina
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 10/1/2008 Female 202 lb 5/29/2009 Physician Australia
Primary
Secondary
Concomitant
Neoplasm Malignant Other Serious 5/11/2009 Female 150 lb 5/29/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 3/10/2009 Female 271 lb 5/29/2009 Physician United States
Primary
Secondary
Concomitant
Lower Limb Fracture Hospitalization 11/30/2007 Female 137 lb 6/3/2009 Physician United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 5/5/2009 76 Female 112 lb 6/5/2009 Physician Germany
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 5/1/2009 Female 246 lb 6/5/2009 Physician United States
Primary
Secondary
Concomitant
Rectal Cancer Other Serious 3/13/2009 Female 146 lb 6/8/2009 Physician United States
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/9/2008 Female 6/15/2009 Physician Malaysia
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/9/2008 Female 6/16/2009 Physician Malaysia
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 5/5/2009 76 Female 112 lb 6/18/2009 Physician Germany
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 4/21/2009 Female 189 lb 6/19/2009 Physician United States
Primary
Secondary
Concomitant
Localised Infection Hospitalization 6/11/2009 6/22/2009 Physician New Zealand
Primary
Secondary
Concomitant
Lower Limb Fracture Hospitalization 11/30/2007 Female 137 lb 6/25/2009 Physician United States
Primary
Secondary
Concomitant
Arthritis Infective Hospitalization 1/11/2009 Female 6/29/2009 Physician New Zealand
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 5/5/2009 76 Female 112 lb 7/1/2009 Physician Germany
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 4/7/2009 Female 112 lb 7/2/2009 Physician Japan
Primary
Secondary
Concomitant
Duodenal Ulcer Hospitalization 6/19/2009 Female 7/2/2009 Physician Japan
Primary
Secondary
Concomitant
Arthritis Infective Hospitalization 1/11/2009 Female 7/6/2009 Physician New Zealand
Primary
Secondary
Concomitant
Influenza Hospitalization 6/14/2009 Male 7/6/2009 Physician Canada
Primary
Secondary
Concomitant
Arthritis Infective Hospitalization 1/11/2009 Female 205 lb 7/8/2009 Physician New Zealand
Primary
Secondary
Concomitant
Duodenal Ulcer Hospitalization 6/19/2009 Female 115 lb 7/9/2009 Physician Japan
Primary
Secondary
Concomitant
Nephritis Hospitalization 6/25/2009 Female 114 lb 7/9/2009 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 7/10/2009 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/17/2009 Female 167 lb 7/10/2009 Physician United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 5/5/2009 76 Female 112 lb 7/13/2009 Physician Germany
Primary
Secondary
Concomitant
Uterine Haemorrhage Hospitalization 1/8/2009 Female 161 lb 7/16/2009 Physician Mexico
Primary
Secondary
Concomitant
Mycobacterium Kansasii Infection 8/1/2008 Male 152 lb 7/20/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/17/2009 Female 167 lb 7/20/2009 Physician United States
Primary
Secondary
Concomitant
Colon Cancer Other Serious 5/11/2009 Female 150 lb 7/20/2009 Physician United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 5/5/2009 76 Female 112 lb 7/21/2009 Physician Germany
Primary
Secondary
Concomitant
Generalised Oedema Hospitalization 6/23/2009 Female 316 lb 7/21/2009 Physician United States
Primary
Secondary
Concomitant
Duodenal Ulcer Hospitalization 6/16/2009 Female 115 lb 7/22/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/7/2009 Female 151 lb 7/22/2009 Physician Argentina
Primary
Secondary
Concomitant
Electrolyte Imbalance Hospitalization 7/1/2009 Female 114 lb 7/24/2009 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 7/24/2009 Physician United States
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 7/27/2009 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/7/2009 Female 151 lb 7/30/2009 Physician Argentina
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 7/31/2009 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/22/2009 Female 131 lb 8/5/2009 Physician Argentina
Primary
Secondary
Concomitant
Sepsis Hospitalization 5/6/2009 Female 196 lb 8/7/2009 Physician United States
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 6/9/2009 Female 189 lb 8/10/2009 Physician United States
Primary
Secondary
Concomitant
Electrolyte Imbalance Hospitalization 6/25/2009 Female 114 lb 8/10/2009 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Mycobacterial Infection Hospitalization 8/1/2009 Female 121 lb 8/14/2009 Physician New Zealand
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 8/18/2009 Physician Canada
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 10/13/2008 Female 254 lb 8/18/2009 Physician United States
Primary
Secondary
Concomitant
Lymph Node Tuberculosis Other Serious 8/29/2008 Female 121 lb 8/19/2009 Physician Mexico
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 8/29/2008 Female 159 lb 8/21/2009 Physician Argentina
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 8/26/2009 Physician Canada
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 8/7/2009 Female 105 lb 8/28/2009 Physician Philippines
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 5/17/2009 23 Male 172 lb 8/28/2009 Physician Germany
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 9/2/2009 Physician Argentina
Primary
Secondary
Concomitant
Osteonecrosis Disability 10/2/2008 Female 144 lb 9/4/2009 Physician Argentina
Primary
Secondary
Concomitant
Diverticulitis Hospitalization 8/7/2009 Female 168 lb 9/11/2009 Physician Finland
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 9/22/2009 Physician Argentina
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Hospitalization 6/14/2009 Male 254 lb 9/24/2009 Physician Canada
Primary
Secondary
Concomitant
Breast Cancer Other Serious 9/10/2009 Female 159 lb 9/24/2009 Physician United States
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 9/25/2009 Physician United States
Primary
Secondary
Concomitant
Pleural Effusion 8/1/2008 Male 152 lb 9/28/2009 Physician United States
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 7/9/2009 Female 189 lb 9/29/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 9/30/2009 Physician Argentina
Primary
Secondary
Concomitant
Intervertebral Disc Disorder Hospitalization 8/1/2009 Female 121 lb 10/2/2009 Physician New Zealand
Primary
Secondary
Concomitant
Viral Infection Hospitalization 9/21/2009 Female 132 lb 10/5/2009 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/22/2009 Female 131 lb 10/6/2009 Physician Argentina
Primary
Secondary
Concomitant
Breast Cancer Other Serious 9/10/2009 Female 159 lb 10/8/2009 Physician United States
Primary
Secondary
Concomitant
Rheumatoid Nodule Other Serious 11/26/2007 Female 166 lb 10/9/2009 Physician Germany
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 8/7/2009 Female 105 lb 10/12/2009 Physician Philippines
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 10/14/2009 Physician Canada
Primary
Secondary
Concomitant
Soft Tissue Infection Hospitalization 8/1/2009 Female 121 lb 10/14/2009 Physician New Zealand
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/6/2009 Female 123 lb 10/14/2009 Physician Malaysia
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/22/2009 Female 131 lb 10/14/2009 Physician Argentina
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/17/2009 Female 167 lb 10/15/2009 Physician United States
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 2/8/2009 Female 88 lb 10/16/2009 Physician Malaysia
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/22/2009 Female 131 lb 10/21/2009 Physician Argentina
Primary
Secondary
Concomitant
Swelling Face Hospitalization 6/14/2009 Male 254 lb 10/23/2009 Physician Canada
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 10/23/2009 Physician Argentina
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 7/9/2009 Female 189 lb 10/26/2009 Physician United States
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 8/7/2009 Female 105 lb 10/30/2009 Physician Philippines
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 10/30/2009 Physician Canada
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 2/8/2009 Female 88 lb 11/2/2009 Physician Malaysia
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 6/12/2009 Female 11/5/2009 Physician Japan
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 11/6/2009 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/6/2009 Female 123 lb 11/6/2009 Physician Malaysia
Primary
Secondary
Concomitant
Colon Cancer Other Serious 10/27/2006 Male 164 lb 11/10/2009 Physician United States
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 10/28/2009 Male 177 lb 11/11/2009 Physician Canada
Primary
Secondary
Concomitant
Viral Infection Hospitalization 9/21/2009 Female 132 lb 11/16/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/31/2009 Male 254 lb 11/16/2009 Physician Canada
Primary
Secondary
Concomitant
Breast Cancer Other Serious 9/10/2009 Female 159 lb 11/17/2009 Physician United States
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 10/15/2009 Female 168 lb 11/20/2009 Physician Finland
Primary
Secondary
Concomitant
Lymph Node Tuberculosis Other Serious 8/29/2008 Female 121 lb 11/23/2009 Physician Mexico
Primary
Secondary
Concomitant
Tachycardia Life Threatening 9/4/2009 Female 157 lb 11/23/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 11/23/2009 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/31/2009 Male 254 lb 11/25/2009 Physician Canada
Primary
Secondary
Concomitant
Bacteraemia Hospitalization 9/18/2009 Female 132 lb 12/1/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/31/2009 Male 254 lb 12/3/2009 Physician Canada
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 10/15/2009 Female 168 lb 12/9/2009 Physician Finland
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 12/11/2009 Physician United States
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 10/28/2009 Male 177 lb 12/16/2009 Physician Canada
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 12/23/2009 Physician United States
Primary
Secondary
Concomitant
Influenza Hospitalization 12/11/2009 Female 12/23/2009 Physician Japan
Primary
Secondary
Breast Mass Hospitalization 12/18/2009 Female 156 lb 12/30/2009 Physician Argentina
Primary
Secondary
Concomitant
Spinal Fracture Life Threatening 12/15/2009 Male 152 lb 12/31/2009 Physician Chile
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 12/17/2009 Female 75 lb 1/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Influenza Hospitalization 12/11/2009 Female 115 lb 1/6/2010 Physician Japan
Primary
Secondary
Concomitant
Breast Mass Hospitalization 12/18/2009 Female 156 lb 1/8/2010 Physician Argentina
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/22/2009 Female 1/8/2010 Physician Argentina
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 1/8/2010 Physician United States
Primary
Secondary
Concomitant
Large Intestine Perforation Life Threatening 9/4/2009 Female 157 lb 1/8/2010 Physician United States
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 10/28/2009 Male 177 lb 1/11/2010 Physician Canada
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Other Serious 12/21/2009 Male 119 lb 1/12/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/22/2009 Female 183 lb 1/14/2010 Physician Argentina
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 1/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization Female 1/21/2010 Physician Japan
Primary
Secondary
Breast Mass Other Serious 10/14/2009 Female 156 lb 1/22/2010 Physician Argentina
Primary
Secondary
Concomitant
Viral Infection Hospitalization 12/17/2009 Female 139 lb 1/22/2010 Physician Canada
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 1/12/2010 Female 1/25/2010 Physician Japan
Primary
Secondary
Pyrexia Hospitalization 9/18/2009 Female 132 lb 1/26/2010 Physician United States
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 4/7/2009 Female 112 lb 1/27/2010 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/26/2009 Female 183 lb 1/28/2010 Physician Argentina
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 1/29/2010 Physician United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Other Serious 12/21/2009 Male 119 lb 2/1/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Viral Infection Hospitalization 12/17/2009 Female 139 lb 2/3/2010 Physician Canada
Primary
Secondary
Concomitant
Breast Cancer Other Serious 9/10/2009 Female 159 lb 2/5/2010 Physician United States
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 4/7/2009 Female 112 lb 2/5/2010 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Hospitalization 12/17/2009 Female 139 lb 2/5/2010 Physician Canada
Primary
Secondary
Concomitant
Sepsis Life Threatening 3/10/2008 Female 106 lb 2/11/2010 Pharmacist Philippines
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 1/12/2010 Female 152 lb 2/11/2010 Physician Japan
Primary
Secondary
Concomitant
Breast Mass Other Serious 10/14/2009 Female 156 lb 2/12/2010 Physician Argentina
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 2/17/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 2/23/2010 Other Health Professional Poland
Primary
Secondary
Concomitant

Drug Data