Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay
Item
participant has genotype 1 chronic hepatitis c with hcv rna level >1000 iu/ml
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
Therapy naive | Hepatitis C Untreated | Therapy Received | Sustained Virologic Response failed | Status post Course Quantity | PEGINTERFERON/RIBAVIRIN | Therapy non-responder | Therapy partial responder | Viral Relapse
Item
participant is either treatment-naïve and did not receive any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis c, or participant is treatment-experienced who did not achieve sustained virologic response (svr) 24 weeks after at least 1 prior course of peg-ifn/rbv therapy (null-responder, partial-responder or viral relapse)
boolean
C0919936 (UMLS CUI [1])
C0019196 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C4050171 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0750729 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C1875630 (UMLS CUI [6])
C0919875 (UMLS CUI [7])
C4285679 (UMLS CUI [8])
C4053867 (UMLS CUI [9])
Biopsy of liver | Fibroscan
Item
participant must have documentation of liver biopsy or fibroscan within 2 years before the screening visit or agree to have a biopsy or fibroscan within the screening period unless histological cirrhosis was demonstrated by a biopsy or fibroscan > 2 years ago prior to screening
boolean
C0193388 (UMLS CUI [1])
C4522043 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods
Item
a female participant of childbearing potential and a nonvasectomized male participant who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female participant ) or 7 months (male participant) after the last dose of rbv
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C0700589 (UMLS CUI [2,4])
Therapy non-responder Previous | Classification Viral Breakthrough
Item
prior non-responder that is classified as a viral breakthrough participant
boolean
C0919875 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0008902 (UMLS CUI [2,1])
C4053869 (UMLS CUI [2,2])
Hepatitis C Genotype | HCV coinfection Genotype
Item
participant is infected or co-infected with hcv of another genotype than genotype 1
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Decompensated liver disease | Liver disease In addition to Hepatitis C
Item
participant has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis c
boolean
C4075847 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
HIV coinfection | HBV coinfection
Item
participant has human immunodeficiency virus (hiv) or hepatitis b virus (hbv) co-infection
boolean
C4062778 (UMLS CUI [1])
C2242656 (UMLS CUI [2])
Malignant disease | Exception Basal cell carcinoma Treated | Exception Liver carcinoma Treated
Item
participant has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma
boolean
C0442867 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C2239176 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])