Incivo combined with Peginterferon Alfa-2A

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Oedema Peripheral Other Serious 11/11/2011 53 Male 3/23/2012 Physician Germany
Primary
Concomitant
Rash Hospitalization 4/13/2012 Physician Germany
Primary
Concomitant
Rash Hospitalization 3/30/2012 68 Female 5/2/2012 Physician Germany
Primary
Concomitant
Arteriovenous Fistula Other Serious 2/6/2012 54 Female 159 lb 5/11/2012 Other Health Professional France
Primary
Concomitant
Inappropriate Schedule Of Drug Administration Other Serious 3/15/2012 69 Female 5/11/2012 Physician Germany
Primary
Concomitant
Rash Hospitalization 3/30/2012 68 Female 5/11/2012 Physician Germany
Primary
Concomitant
Rash Hospitalization 3/30/2012 68 Female 5/16/2012 Physician Germany
Primary
Concomitant
Syncope 3/15/2012 69 Female 5/21/2012 Physician Germany
Primary
Concomitant
Cardiac Failure Other Serious 12/15/2011 53 Male 5/29/2012 Physician Germany
Primary
Concomitant
General Physical Health Deterioration Hospitalization 3/11/2012 Female 6/1/2012 Physician Germany
Primary
Concomitant
Pulmonary Oedema Other Serious 5/24/2012 Female 6/4/2012 Physician Spain
Primary
Concomitant
Death Death 4/14/2012 53 Male 6/4/2012 Physician France
Primary
Secondary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Hospitalization 4/25/2012 51 Male 6/7/2012 Physician Germany
Primary
Concomitant
Acute Hepatic Failure Death 3/21/2012 Male 6/12/2012 Physician Germany
Primary
Concomitant
Death Death 4/4/2012 53 Male 6/12/2012 Physician France
Primary
Concomitant
Eosinophilia Hospitalization 4/1/2012 61 Female 6/13/2012 Physician Germany
Primary
Concomitant
Malaise Death 5/24/2012 Female 6/14/2012 Physician Spain
Primary
Concomitant
General Physical Health Deterioration Hospitalization 3/11/2012 Female 6/18/2012 Physician Germany
Primary
Concomitant
Dyspnoea Other Serious 5/24/2012 Female 6/20/2012 Physician Spain
Primary
Concomitant
Rash Hospitalization 4/17/2012 Female 6/20/2012 Physician Spain
Primary
Concomitant
Rash Macular Hospitalization 5/17/2012 Male 6/21/2012 Physician United Kingdom
Primary
Concomitant
Death Death 4/14/2012 53 Male 6/25/2012 Physician France
Primary
Secondary
Concomitant
Drug Interaction Other Serious Male 6/29/2012 Physician Greece
Primary
Concomitant
Interacting
Death Hospitalization 4/4/2012 53 Male 7/2/2012 Physician France
Primary
Concomitant
Haemorrhoids Other Serious 4/20/2012 49 Male 7/4/2012 Other Health Professional United Kingdom
Primary
Concomitant
Off Label Use Other Serious 6/8/2012 Male 129 lb 7/5/2012 Physician Portugal
Primary
Concomitant
Haemorrhoids Other Serious 4/20/2012 49 Male 7/5/2012 Other Health Professional United Kingdom
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 45 Male 7/5/2012 Physician France
Primary
Concomitant
Thrombocytopenia Hospitalization Male 7/5/2012 Physician France
Primary
Concomitant
Blister Other Serious 6/23/2012 45 Male 150 lb 7/5/2012 Physician France
Primary
Concomitant
Rash Pruritic Other Serious 6/15/2012 37 Male 7/6/2012 Other Health Professional United Kingdom
Primary
Concomitant
Vision Blurred Other Serious 5/23/2012 48 Male 7/6/2012 Other Health Professional United Kingdom
Primary
Concomitant
Haematocrit Decreased Other Serious Male 7/12/2012 Physician Greece
Primary
Concomitant
Interacting
Mood Swings Other Serious 6/18/2012 43 Male 7/12/2012 Other Health Professional United Kingdom
Primary
Concomitant
Neutropenia Other Serious 4/23/2012 53 Female 128 lb 7/13/2012 Physician Romania
Primary
Concomitant
Anaemia Hospitalization 4/4/2012 54 Male 7/16/2012 Physician Spain
Primary
Concomitant
Haemolytic Anaemia Other Serious 7/16/2012 Physician Denmark
Primary
Concomitant
Haemolytic Anaemia Other Serious Unknown 7/17/2012 Physician Denmark
Primary
Concomitant
Proctalgia Other Serious 6/18/2012 43 Male 7/18/2012 Other Health Professional United Kingdom
Primary
Concomitant
Atrial Fibrillation Other Serious Male 7/18/2012 Physician Greece
Primary
Concomitant
Interacting
Insomnia Other Serious 5/28/2012 57 Male 7/23/2012 Other Health Professional United Kingdom
Primary
Concomitant
White Blood Cell Count Abnormal Hospitalization 3/26/2012 63 Female 7/25/2012 Physician Spain
Primary
Concomitant
Rash Other Serious Male 7/25/2012 Physician Greece
Primary
Concomitant
Interacting
Neutropenia Life Threatening 4/23/2012 53 Female 128 lb 7/26/2012 Physician Romania
Primary
Concomitant
Rash Other Serious Male 7/31/2012 Physician Greece
Primary
Concomitant
Interacting
Influenza Other Serious 5/28/2012 57 Male 7/31/2012 Other Health Professional United Kingdom
Primary
Concomitant
Rash Other Serious Male 8/3/2012 Physician Greece
Primary
Concomitant
Nausea Other Serious Female 8/3/2012 Other Health Professional United Kingdom
Primary
Concomitant
Rash Other Serious 5/14/2012 49 Male 8/6/2012 Physician Spain
Primary
Concomitant
Leukopenia Other Serious 6/2/2012 63 Male 212 lb 8/8/2012 Physician Netherlands
Primary
Concomitant
Influenza Other Serious 5/28/2012 57 Male 8/9/2012 Other Health Professional United Kingdom
Primary
Concomitant
Proctalgia Other Serious 7/28/2012 Male 8/9/2012 Physician Portugal
Primary
Concomitant
Death Other Serious 4/20/2012 69 Male 8/10/2012 Physician Germany
Primary
Concomitant
Acute Hepatic Failure Other Serious 3/21/2012 Male 8/10/2012 Physician Germany
Primary
Concomitant
Haemorrhoids Other Serious 5/1/2012 55 Male 161 lb 8/13/2012 Physician Germany
Primary
Concomitant
Rash Hospitalization 6/11/2012 42 Male 168 lb 8/13/2012 Physician Germany
Primary
Concomitant
Fatigue 5/1/2012 55 Male 161 lb 8/14/2012 Physician Germany
Primary
Concomitant
Lung Infection Hospitalization 2/15/2012 55 Male 176 lb 8/14/2012 Turkey
Primary
Concomitant
Rash Hospitalization Male 168 lb 8/14/2012 Physician Germany
Primary
Concomitant
Splenomegaly Death 4/20/2012 69 Male 9/5/2012 Other Health Professional De
Primary
Secondary
Concomitant
Varices Oesophageal Hospitalization 8/10/2012 64 Female 10/17/2012 Consumer Us
Primary
Secondary
Concomitant
Portal Vein Thrombosis Death NotSpecified 3/20/2013 Physician Es
Primary
Concomitant
Adverse Drug Reaction Other Serious 71 Male 141 lb 9/25/2012 Physician De
Primary
Secondary
Pneumonia Bacterial Hospitalization 51 Male 176 lb 10/2/2012 Physician De
Primary
Secondary
Thrombocytopenia Hospitalization 6/2/2012 63 Male 212 lb 9/28/2012 Physician Nl
Primary
Secondary
Vascular Purpura Other Serious 58 Male 10/5/2012 Other Health Professional Fr
Primary
Concomitant
Surgery Other Serious 8/18/2012 53 Male 157 lb 5/23/2013 Other Health Professional Gb
Primary
Secondary
Concomitant
Rash Hospitalization 9/18/2012 Male 196 lb 1/2/2013 Consumer De
Primary
Secondary
Face Oedema Other Serious 11/18/2011 53 Male 187 lb 10/26/2012 Consumer Gb
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 10/11/2012 24 Male 1/17/2013 Physician De
Primary
Secondary
Concomitant
Depression Other Serious 12/7/2012 Consumer De
Primary
Secondary
Pancytopenia Hospitalization 10/22/2012 66 Female 121 lb 12/4/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Rash Other Serious 56 Male 11/21/2012 Consumer Fr
Primary
Concomitant
Tongue Pigmentation Other Serious 7/28/2012 33 Male 11/29/2012 Physician Pt
Primary
Concomitant
Tongue Pigmentation Other Serious 7/28/2012 33 Male 7/30/2013 Physician Pt
Primary
Concomitant
Vomiting Hospitalization 7/31/2012 38 Female 2/21/2013 Physician At
Primary
Secondary
Concomitant
Eye Infection Bacterial Hospitalization 11/29/2012 53 Female 117 lb 12/18/2012 Physician Nl
Primary
Secondary
Acute Psychosis Other Serious 9/24/2012 47 Male 2/13/2013 Other Health Professional Gb
Primary
Secondary
Concomitant
Abdominal Pain Hospitalization 1/4/2012 34 Male 209 lb 3/11/2013 Consumer De
Primary
Secondary
Rash Other Serious 1/8/2012 55 Male 181 lb 1/11/2013 Physician De
Primary
Secondary
Skin Lesion Hospitalization 10/23/2012 54 Female 137 lb 10/29/2013 Physician Il
Primary
Secondary
Oedema Other Serious 11/16/2011 76 Female 148 lb 2/8/2013 Consumer De
Primary
Secondary
Skin Fissures Other Serious 11/22/2012 Male 2/21/2013 Other Health Professional Gb
Primary
Concomitant
Rash Hospitalization 12/27/2012 73 Female 3/29/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Oedema Hospitalization 11/30/2011 56 Female 117 lb 2/7/2013 Consumer De
Primary
Secondary
Oedema Hospitalization 11/30/2011 56 Female 117 lb 2/12/2013 Other Health Professional De
Primary
Secondary
Rash Morbilliform Other Serious 1/25/2013 57 Male 177 lb 2/26/2013 Other Health Professional Au
Primary
Secondary
Concomitant
Polyneuropathy Other Serious 1/14/2013 50 Male 3/7/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Vomiting Hospitalization 12/2012 51 NotSpecified 2/28/2013 Pharmacist Gb
Primary
Secondary
Concomitant
Face Oedema Hospitalization 12/13/2012 68 Female 3/1/2013 Other Health Professional Il
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 2/13/2013 57 Female 7/23/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Mallory-weiss Syndrome Hospitalization 12/25/2012 71 Female 3/6/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Toxic Skin Eruption Hospitalization 9/23/2012 46 Female 3/7/2013 Pharmacist Es
Primary
Secondary
Fluid Retention Hospitalization 2/26/2013 54 Female 7/17/2013 Consumer De
Primary
Secondary
Concomitant
Orchitis Other Serious 11/22/2012 50 Male 154 lb 3/13/2013 Other Health Professional Gb
Primary
Secondary
Urinary Tract Infection Hospitalization 1/18/2013 62 Female 106 lb 3/28/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Thermal Burn Hospitalization 2/20/2013 57 Male 3/29/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Leukocytosis Other Serious 52 Male 12/16/2013 Physician Tr
Primary
Secondary
Skin Odour Abnormal Other Serious 3/13/2013 62 Male 203 lb 5/20/2013 Consumer Co
Primary
Concomitant
Inappropriate Schedule Of Drug Administration Hospitalization 11/19/2012 47 Male 4/2/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Rash Hospitalization 3/19/2013 45 Female 220 lb 5/7/2013 Other Health Professional Be
Primary
Secondary
Concomitant
Sepsis Hospitalization 3/18/2013 62 Male 179 lb 4/2/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Diarrhoea Life Threatening 2/23/2012 67 Female 6/27/2013 Consumer De
Primary
Secondary
Concomitant
Venous Occlusion Hospitalization 11/19/2011 Male 154 lb 4/11/2013 Consumer De
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 8/10/2012 64 Female 6/13/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Pneumothorax Hospitalization 2/1/2013 54 Male 126 lb 7/8/2013 Consumer Gb
Primary
Secondary
Concomitant
Weight Decreased Other Serious 65 Female 4/12/2013 Physician Tr
Primary
Secondary
Rash Hospitalization 55 Male 12/19/2013 Physician Tr
Primary
Secondary
Rash Hospitalization 46 Female 12/19/2013 Physician Tr
Primary
Secondary
Vomiting Other Serious 3/15/2013 69 Female 117 lb 6/7/2013 Consumer Co
Primary
Concomitant
Drug Reaction With Eosinophilia And Systemic Symptoms Hospitalization 3/20/2013 34 Female 127 lb 5/8/2013 Other Health Professional Gb
Primary
Secondary
Concomitant
Virologic Failure Other Serious NotSpecified 5/2/2013 Consumer Fr
Primary
Secondary
Concomitant
Pyrexia Hospitalization 3/13/2013 65 Female 9/19/2013 Other Health Professional Fr
Primary
Secondary
Deep Vein Thrombosis Hospitalization 3/22/2013 74 Male 6/21/2013 Other Health Professional Gb
Primary
Secondary
Rash Other Serious 5/3/2013 60 Female 11/15/2013 Physician Gb
Primary
Secondary
Vomiting Other Serious 2012 61 Female 6/6/2013 Physician Ch
Primary
Concomitant
Urinary Tract Infection Life Threatening 4/2012 62 Female 181 lb 7/11/2013 Consumer De
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization NotSpecified 7/18/2013 Other Health Professional At
Primary
Secondary
Skin Disorder Other Serious NotSpecified 5/23/2013 Consumer De
Primary
Secondary
Off Label Use Death 52 Female 6/11/2013 Consumer Es
Primary
Concomitant
Rash Other Serious 3/28/2013 Male 209 lb 6/21/2013 Consumer De
Primary
Secondary
Thrombocytopenia Hospitalization 1/23/2013 66 Male 10/31/2013 Physician Be
Primary
Secondary
Concomitant
Off Label Use Other Serious 58 Male 146 lb 6/13/2013 Other Health Professional De
Primary
Secondary
Pyelonephritis Hospitalization 5/22/2013 57 Female 6/24/2013 Other Health Professional Fr
Primary
Secondary
Pyrexia Hospitalization 5/2013 52 Female 10/16/2013 Physician Fr
Primary
Secondary
Concomitant
Tooth Abscess Hospitalization 4/2013 52 Female 7/15/2013 Consumer Gb
Primary
Secondary
Concomitant
Anal Fistula Hospitalization 3/4/2013 57 Male 7/9/2013 Consumer De
Primary
Secondary
Diffuse Large B-cell Lymphoma Hospitalization 6/2013 57 Male 141 lb 8/6/2013 Physician Nl
Primary
Concomitant
Skin Disorder Other Serious 5/13/2013 Male 176 lb 8/6/2013 Consumer De
Primary
Secondary
Skin Disorder Other Serious 12/30/2008 NotSpecified 8/8/2013 Physician Be
Primary
Secondary
Concomitant
Underdose Hospitalization 5/22/2013 66 Male 9/6/2013 Physician It
Primary
Secondary
Pancreatitis Acute Other Serious 7/25/2013 52 Female 8/27/2013 Physician Es
Primary
Secondary
Pathogen Resistance Other Serious 42 Male 9/6/2013 Physician Fr
Primary
Secondary
Rash Generalised Other Serious 6/4/2013 40 Male 10/21/2013 Physician Ar
Primary
Secondary
Rash Hospitalization 8/1/2013 Female 141 lb 9/20/2013 Physician De
Primary
Secondary
Rash Other Serious 4/30/2013 NotSpecified 9/20/2013 Physician Fr
Primary
Secondary
White Blood Cell Count Decreased Other Serious 10/17/2012 62 Male 9/23/2013 Registered Nurse Gb
Primary
Secondary
Rash Hospitalization 7/5/2013 55 Male 10/18/2013 Physician Fr
Primary
Secondary
Concomitant
Toxic Skin Eruption Other Serious 48 Male 10/7/2013 Pharmacist Nl
Primary
Secondary
Influenza Like Illness Other Serious 56 Female 10/7/2013 Physician Ch
Primary
Secondary
Pruritus Other Serious 1/7/2013 46 Male 10/16/2013 Other Health Professional Gb
Primary
Secondary
Off Label Use Death NotSpecified 10/22/2013 Other Health Professional Fr
Primary
Secondary
Thrombocytopenia Hospitalization NotSpecified 10/22/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Thirst Other Serious 3/19/2013 41 Female 110 lb 10/25/2013 Other Health Professional Gb
Primary
Secondary
Concomitant
Thirst Hospitalization 2/19/2013 41 Female 10/25/2013 Registered Nurse Gb
Primary
Secondary
Concomitant
Sciatica Hospitalization 5/13/2013 40 Female 11/14/2013 Physician Be
Primary
Secondary
Oedema Hospitalization 12/28/2012 46 Male 11/14/2013 Physician De
Primary
Secondary
Suicide Attempt Other Serious Male 11/18/2013 Physician Pt
Primary
Concomitant
Septic Shock Death 55 Male 12/2/2013 Consumer Br
Primary
Secondary
Thrombocytopenia Death NotSpecified 12/11/2013 Physician Fr
Primary
Secondary

Drug Data