Chronic Hepatitis C Genotype | Hepatitis C virus RNA assay
Item
patient has chronic hcv infection genotype 1 with hcv rna level > 1,000 iu/ml
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1272251 (UMLS CUI [2])
Hepatitis C Untreated
Item
patients should not have had any previous treatment for hepatitis c
boolean
C0019196 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Biopsy of liver
Item
patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
boolean
C0193388 (UMLS CUI [1])
Liver Cirrhosis | Serum alpha-fetoprotein (AFP) measurement | Tumor Mass Absent Ultrasonography
Item
patients with cirrhosis should have serum alpha-fetoprotein (afp) <= 50 ng/ml. if afp > 50 ng/ml, absence of a mass must be demonstrated by ultrasound within the screening period
boolean
C0023890 (UMLS CUI [1])
C0546833 (UMLS CUI [2])
C3273930 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
Childbearing Potential Contraceptive methods Quantity | Gender Partner Childbearing Potential Contraceptive methods
Item
a female patient of childbearing potential and a nonvasectomized male patient 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 patient) or 7 months (male patient) 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])
Hepatitis C Genotype | HCV coinfection Genotype | Hepatitis C Genotype Quantity
Item
patient is infected or co-infected with hcv of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C1698259 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C1148363 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Mental disorder Pre-existing
Item
patient has a pre-existing psychiatric condition
boolean
C0004936 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Decompensated liver disease | Liver disease In addition to Hepatitis C
Item
patient 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
patient 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
Item
patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
boolean
C0442867 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])