Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
Age
Item
adult patients >=18 years of age
boolean
Chronic Hepatitis C
Item
CHC infection
boolean
Liver biopsy
Item
liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection
boolean
Contraception men and women
Item
use of 2 forms of contraception during study and 6 months after the study in both men and women
boolean
Previous medication
Item
Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks
boolean
Item Group
Exclusion criteria
Pregnancy / Lactation
Item
women who are pregnant or breastfeeding
boolean
Pregnant partners
Item
male partners of women who are pregnant
boolean
Decompensated liver disease
Item
conditions associated with decompensated liver disease
boolean
Other liver disease
Item
other forms of liver disease, including liver cancer
boolean
HIV
Item
human immunodeficiency virus infection
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
CHC
Item
Chronic hepatitis C
string
C0524910 (UMLS CUI)
128302006 (SNOMED CT 2010_0731)
10008912 (MedDRA 13.1)
Diagnostic procedure
Item
Diagnostic procedure
string
C0430022 (UMLS CUI)
103693007 (SNOMED CT 2010_0731)
10061816 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Advanced chronic liver disease
Item
Advanced chronic liver disease
string
C0860197 (UMLS CUI)
10001422 (MedDRA 13.1)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)

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