Blinded; Golimuma combined with Placebo

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Bone Neoplasm Hospitalization 1/1/2009 Female 115 lb 5/7/2009 Physician Japan
Primary
Secondary
Concomitant
Bone Neoplasm Hospitalization 1/1/2009 Female 115 lb 5/11/2009 Physician Japan
Primary
Secondary
Concomitant
Cellulitis Hospitalization 12/31/2008 Male 126 lb 5/19/2009 Physician Japan
Primary
Secondary
Concomitant
Infection Hospitalization 4/6/2009 Male 163 lb 5/19/2009 Physician France
Primary
Secondary
Concomitant
Erythema Nodosum Hospitalization 4/23/2009 Female 163 lb 5/19/2009 Physician Austria
Primary
Secondary
Concomitant
Infection Hospitalization 4/6/2009 Male 163 lb 5/19/2009 Physician France
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/14/2009 Female 132 lb 5/21/2009 Physician Japan
Primary
Secondary
Infection Hospitalization 4/6/2009 Male 163 lb 5/21/2009 Physician France
Primary
Secondary
Concomitant
Malaise Hospitalization 4/28/2009 Male 183 lb 5/21/2009 Physician Australia
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/14/2009 Female 132 lb 5/28/2009 Physician Japan
Primary
Secondary
Concomitant
Infection Hospitalization 4/6/2009 Male 163 lb 5/28/2009 Physician France
Primary
Secondary
Concomitant
Haemoglobin Decreased Other Serious 4/23/2009 Female 163 lb 6/3/2009 Physician Austria
Primary
Secondary
Concomitant
Teratoma Hospitalization 2/23/2009 Female 6/5/2009 Physician Japan
Primary
Secondary
Malaise Hospitalization 4/28/2009 Male 183 lb 6/8/2009 Physician Australia
Primary
Secondary
Concomitant
Bone Neoplasm Hospitalization 1/1/2009 Female 115 lb 6/9/2009 Physician Japan
Primary
Secondary
Concomitant
Erythema Nodosum Other Serious 4/23/2009 Female 163 lb 6/9/2009 Physician Austria
Primary
Secondary
Concomitant
Cellulitis Hospitalization 6/12/2009 Female 6/22/2009 Physician Japan
Primary
Secondary
Cellulitis Hospitalization 6/12/2009 Female 6/24/2009 Physician Japan
Primary
Secondary
Infection Hospitalization 6/15/2009 Female 192 lb 6/26/2009 Physician Australia
Primary
Secondary
Pneumonia Hospitalization 5/14/2009 Female 132 lb 6/26/2009 Physician Japan
Primary
Secondary
Concomitant
Bone Neoplasm Hospitalization 2/12/2009 Female 115 lb 6/29/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/24/2009 Male 143 lb 7/2/2009 Physician Bulgaria
Primary
Secondary
Concomitant
Teratoma Hospitalization 2/23/2009 Female 7/2/2009 Physician Japan
Primary
Secondary
Breast Abscess Hospitalization 6/15/2009 Female 192 lb 7/13/2009 Physician Australia
Primary
Secondary
Teratoma Hospitalization 2/23/2009 Female 7/14/2009 Physician Japan
Primary
Secondary
Hepatic Steatosis Hospitalization 5/20/2009 Male 7/16/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Meningitis Viral Hospitalization 7/15/2009 Female 130 lb 7/23/2009 Physician Austria
Primary
Secondary
Concomitant
Subileus Hospitalization 4/7/2009 Male 163 lb 7/24/2009 Physician France
Primary
Secondary
Concomitant
Breast Abscess Hospitalization 6/15/2009 Female 192 lb 7/24/2009 Physician Australia
Primary
Secondary
Concomitant
Septic Shock Hospitalization 7/11/2009 Female 79 lb 7/27/2009 Physician India
Primary
Secondary
Septic Shock Hospitalization 7/11/2009 Female 79 lb 7/28/2009 Physician India
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 9/6/2008 Male 161 lb 7/30/2009 Physician Israel
Primary
Secondary
Concomitant
Congenital Teratoma Other Serious 7/20/2008 Male 159 lb 7/30/2009 Physician Belgium
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 6/12/2009 Female 7/31/2009 Physician Japan
Primary
Secondary
Urinary Tract Infection Hospitalization 7/24/2009 Female 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Infected Cyst Other Serious 7/20/2009 Male 159 lb 8/6/2009 Physician Belgium
Primary
Secondary
Concomitant
Septic Shock Hospitalization 7/11/2009 Female 79 lb 8/12/2009 Physician India
Primary
Secondary
Concomitant
Septic Shock Hospitalization 7/11/2009 Female 79 lb 8/14/2009 Physician India
Primary
Secondary
Concomitant
Polyserositis Hospitalization 6/24/2009 Female 8/14/2009 Physician Austria
Primary
Secondary
Concomitant
Septic Shock Hospitalization 7/11/2009 Female 79 lb 8/19/2009 Physician India
Primary
Secondary
Concomitant
Bone Neoplasm Hospitalization 2/12/2009 Female 115 lb 8/20/2009 Physician Japan
Primary
Secondary
Concomitant
Teratoma Hospitalization 2/23/2009 Female 8/20/2009 Physician Japan
Primary
Secondary
Concomitant
Breast Abscess Hospitalization 6/15/2009 Female 192 lb 8/24/2009 Physician Australia
Primary
Secondary
Concomitant
Septic Shock Hospitalization 7/11/2009 Female 79 lb 8/25/2009 Physician India
Primary
Secondary
Concomitant
Colitis Hospitalization 6/3/2009 Male 8/28/2009 Physician Israel
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 8/17/2009 Male 172 lb 8/28/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/14/2009 Female 132 lb 9/2/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 4/22/2008 Female 206 lb 9/3/2009 Physician New Zealand
Primary
Secondary
Concomitant
Septic Shock Hospitalization 7/11/2009 Female 79 lb 9/3/2009 Physician India
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 8/16/2009 Male 172 lb 9/3/2009 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/24/2009 Female 9/4/2009 Physician Japan
Primary
Secondary
Concomitant
Encephalitis Hospitalization 7/15/2009 Female 130 lb 9/8/2009 Physician Austria
Primary
Secondary
Concomitant
Septic Shock Hospitalization 7/11/2009 Female 79 lb 9/9/2009 Physician India
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 6/12/2009 Female 9/11/2009 Physician Japan
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 8/16/2009 Male 172 lb 9/14/2009 Physician United States
Primary
Secondary
Concomitant
Encephalitis Hospitalization 7/15/2009 Female 130 lb 9/15/2009 Physician Austria
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization 9/9/2009 Male 190 lb 9/18/2009 Physician Australia
Primary
Secondary
Concomitant
Colitis Hospitalization 6/3/2009 Male 132 lb 9/29/2009 Physician Israel
Primary
Secondary
Concomitant
Colitis Hospitalization 6/3/2009 Male 132 lb 10/2/2009 Physician Israel
Primary
Secondary
Concomitant
Vascular Rupture Life Threatening 9/2/2009 Male 209 lb 10/9/2009 Other Health Professional Denmark
Primary
Secondary
Concomitant
Breast Cancer Hospitalization 1/1/2009 Female 119 lb 10/16/2009 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 6/12/2009 Female 10/21/2009 Physician Japan
Primary
Secondary
Concomitant
Gastroenteritis Rotavirus Hospitalization 5/20/2009 Male 10/23/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Demyelination Other Serious 7/14/2009 Male 306 lb 10/26/2009 Physician United States
Primary
Secondary
Concomitant
Breast Abscess Hospitalization 6/15/2009 Female 192 lb 10/28/2009 Physician Australia
Primary
Secondary
Concomitant
Gastroenteritis Bacterial Hospitalization 10/8/2009 Male 132 lb 11/6/2009 Physician Japan
Primary
Secondary
Concomitant
Malaise Hospitalization 4/28/2009 Male 183 lb 11/12/2009 Physician Australia
Primary
Secondary
Concomitant
Gastroenteritis Bacterial Hospitalization 10/8/2009 Male 132 lb 11/12/2009 Physician Japan
Primary
Secondary
Concomitant
Breast Abscess Hospitalization 6/15/2009 Female 192 lb 11/17/2009 Physician Australia
Primary
Secondary
Concomitant
Colitis Ulcerative Hospitalization 9/9/2009 Male 190 lb 11/19/2009 Physician Australia
Primary
Secondary
Concomitant
Colitis Hospitalization 6/3/2009 Male 132 lb 11/19/2009 Physician Israel
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 11/23/2009 Physician Japan
Primary
Secondary
Concomitant
Enterocolitis Infectious Hospitalization 10/8/2009 Male 132 lb 11/23/2009 Physician Japan
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 8/16/2009 Male 172 lb 11/23/2009 Physician United States
Primary
Secondary
Concomitant
Vascular Rupture Life Threatening 9/2/2009 Male 209 lb 11/24/2009 Other Health Professional Denmark
Primary
Secondary
Concomitant
Gastroenteritis Viral Hospitalization 4/28/2009 Male 183 lb 11/24/2009 Physician Australia
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/20/2009 12/11/2009 Physician Japan
Primary
Secondary
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 12/15/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/20/2009 Male 119 lb 12/18/2009 Physician Japan
Primary
Secondary
Pneumonia Hospitalization 11/20/2009 Male 119 lb 12/22/2009 Physician Japan
Primary
Secondary
Cytomegalovirus Infection Hospitalization 12/7/2009 Male 154 lb 12/23/2009 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/7/2009 12/23/2009 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/7/2009 12/30/2009 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 12/7/2009 Male 154 lb 12/30/2009 Physician Japan
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 1/5/2010 Physician Japan
Primary
Secondary
Concomitant
Pyoderma Gangrenosum Hospitalization 10/20/2009 Female 114 lb 1/8/2010 Physician Japan
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 12/7/2009 Male 154 lb 1/18/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 6/15/2009 Female 192 lb 1/21/2010 Physician Australia
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 12/7/2009 Male 154 lb 1/21/2010 Physician Japan
Primary
Secondary
Concomitant
Enterocolitis Infectious Hospitalization 10/8/2009 Male 132 lb 1/27/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/1/2009 Male 154 lb 1/31/2010 Physician Japan
Primary
Secondary
Concomitant
Rectal Cancer Other Serious 11/30/2009 Female 81 lb 1/31/2010 Physician Japan
Primary
Secondary
Concomitant
Gastroenteritis Rotavirus Hospitalization 5/20/2009 Male 2/1/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Rectal Cancer Other Serious 11/30/2009 Female 81 lb 2/4/2010 Physician Japan
Primary
Secondary
Concomitant
Breast Neoplasm Life Threatening 1/20/2010 Female 198 lb 2/9/2010 Physician Denmark
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/20/2009 Male 119 lb 2/11/2010 Physician Japan
Primary
Secondary
Pyrexia Hospitalization 12/1/2009 Male 154 lb 2/12/2010 Physician Japan
Primary
Secondary
Concomitant
Pyoderma Gangrenosum Hospitalization 10/20/2009 Female 114 lb 2/19/2010 Physician Japan
Primary
Secondary
Concomitant
Abscess Intestinal Hospitalization 1/23/2010 Female 249 lb 2/19/2010 Physician Australia
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 2/25/2010 Physician Japan
Primary
Secondary
Concomitant
Colectomy Hospitalization 12/18/2008 Female 3/2/2010 Physician Australia
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 12/7/2009 Female 3/5/2010 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Streptococcal Infection Hospitalization 11/20/2009 Male 119 lb 3/10/2010 Physician Japan
Primary
Secondary
Herpes Zoster Hospitalization 12/7/2009 Female 3/10/2010 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Pneumonia Streptococcal Hospitalization 11/23/2009 Male 119 lb 3/11/2010 Physician Japan
Primary
Secondary
Abscess Neck Hospitalization 2/28/2010 Female 194 lb 3/12/2010 Physician Australia
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/13/2009 Female 108 lb 3/12/2010 Physician Hungary
Primary
Secondary
Concomitant
Abscess Intestinal Hospitalization 1/23/2010 Female 249 lb 3/16/2010 Physician Australia
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/13/2009 Female 108 lb 3/18/2010 Physician Hungary
Primary
Secondary
Concomitant
Abscess Neck Hospitalization 2/28/2010 Female 194 lb 3/19/2010 Physician Australia
Primary
Secondary
Concomitant
Abscess Intestinal Hospitalization 1/23/2010 Female 249 lb 3/26/2010 Physician Australia
Primary
Secondary
Concomitant
Breast Cancer Other Serious 1/20/2010 52 Female 198 lb 4/6/2010 Physician Denmark
Primary
Secondary
Concomitant
Colitis Ulcerative Other Serious 10/24/2007 20 Male 141 lb 4/7/2010 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/25/2010 33 Male 168 lb 4/7/2010 Physician Hungary
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/25/2010 33 Male 168 lb 4/8/2010 Physician Hungary
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/23/2009 55 Male 119 lb 4/8/2010 Physician Japan
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 28 Female 114 lb 4/9/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/25/2010 33 Male 168 lb 4/12/2010 Physician Hungary
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/25/2010 33 Male 168 lb 4/13/2010 Physician Hungary
Primary
Secondary
Concomitant
Otitis Externa Hospitalization 4/4/2010 26 Female 243 lb 4/15/2010 Physician Germany
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 28 Female 114 lb 4/15/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/25/2010 33 Male 168 lb 4/19/2010 Physician Hungary
Primary
Secondary
Concomitant
Colitis Ulcerative Other Serious 10/10/2007 20 Male 141 lb 4/30/2010 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/20/2010 46 Female 134 lb 4/30/2010 Physician Hungary
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 11/8/2009 28 Female 114 lb 4/30/2010 Physician Japan
Primary
Secondary
Concomitant
Enterocolitis Infectious Hospitalization 10/8/2009 20 Male 132 lb 5/4/2010 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Hospitalization 11/28/2009 30 Male 170 lb 5/10/2010 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/25/2010 33 Male 168 lb 5/19/2010 Physician Hungary
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Hospitalization 5/12/2010 49 Male 236 lb 5/21/2010 Physician Australia
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 11/8/2009 28 Female 114 lb 5/27/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 3/1/2010 34 Female 128 lb 5/28/2010 Physician Canada
Primary
Secondary
Concomitant
Lung Adenocarcinoma Other Serious 3/8/2010 71 Female 183 lb 6/7/2010 Physician New Zealand
Primary
Secondary
Concomitant
Colitis Ulcerative Other Serious 10/10/2007 20 Male 141 lb 6/7/2010 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/20/2010 46 Female 134 lb 6/8/2010 Physician Hungary
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/6/2010 60 Female 175 lb 6/11/2010 Physician Ukraine
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 4/22/2008 39 Female 206 lb 6/22/2010 Physician New Zealand
Primary
Secondary
Concomitant
Sepsis Hospitalization 2/12/2010 56 Male 227 lb 6/25/2010 Physician Germany
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 6/15/2010 64 Female 129 lb 6/30/2010 Physician United States
Primary
Secondary
Concomitant
Haemoglobin Decreased Hospitalization 6/15/2010 64 Female 129 lb 7/9/2010 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/24/2009 60 Male 143 lb 7/9/2010 Physician Bulgaria
Primary
Secondary
Concomitant
Sepsis Hospitalization 2/12/2010 56 Male 227 lb 7/12/2010 Physician Germany
Primary
Secondary
Concomitant
Viral Infection Hospitalization 11/28/2009 30 Male 170 lb 7/12/2010 Physician Germany
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 6/15/2010 64 Female 129 lb 7/13/2010 Physician United States
Primary
Secondary
Concomitant
Intra-uterine Death Other Serious 3/19/2009 27 Female 140 lb 7/15/2010 Physician United States
Primary
Secondary
Concomitant
Meningitis Viral Hospitalization 7/6/2010 27 Male 181 lb 7/23/2010 Physician Germany
Primary
Secondary
Concomitant
Latent Tuberculosis Hospitalization 4/9/2010 58 Male 157 lb 7/27/2010 Other Health Professional Poland
Primary
Secondary
Concomitant
Colitis Hospitalization 6/3/2009 22 Male 132 lb 7/30/2010 Physician Israel
Primary
Secondary
Concomitant
Enterocolitis Infectious Hospitalization 10/13/2009 20 Male 132 lb 7/30/2010 Physician Japan
Primary
Secondary
Concomitant
Colon Cancer Other Serious 7/15/2010 52 Female 173 lb 7/30/2010 Physician Germany
Primary
Secondary
Concomitant
Pyrexia Hospitalization 1/18/2009 33 Male 95 lb 8/5/2010 Physician India
Primary
Secondary
Concomitant

Drug Data