Chronic Hepatitis C Genotype
Item
patients chronically infected with hcv genotype-1b
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive | Recurrent disease Post Treatment completed
Item
naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines)
boolean
C0919936 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0580352 (UMLS CUI [2,3])
Hepatitis C virus RNA Viral load measurement
Item
hcv rna viral load ≥100,000 iu/ml at screening
boolean
C0369335 (UMLS CUI [1,1])
C1261478 (UMLS CUI [1,2])
Compensated cirrhosis
Item
patients with compensated cirrhosis are permitted
boolean
C1608426 (UMLS CUI [1])
Hepatitis C | Exception Genotype determination
Item
infection with hepatitis c virus (hcv) other than genotype-1b
boolean
C0019196 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1533728 (UMLS CUI [2,2])
Hepatitis B surface antigen positive | Human immunodeficiency virus type 1 antibody Positive | Human immunodeficiency virus, type II antibody Positive
Item
positive hepatitis b surface antigen (hbsag) or human immunodeficiency virus (hiv)-1/hiv-2 antibody test at screening
boolean
C0149709 (UMLS CUI [1])
C0369497 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0369500 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Chronic liver disease caused by Disease | Exception Chronic Hepatitis C
Item
evidence of chronic liver disease caused by diseases other than chronic hcv infection
boolean
C0341439 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Bleeding varices | Hepatic Encephalopathy | Ascites Requirement Diuretics | Ascites Requirement Paracentesis
Item
current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
boolean
C0333106 (UMLS CUI [1])
C0019151 (UMLS CUI [2])
C0003962 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0012798 (UMLS CUI [3,3])
C0003962 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0034115 (UMLS CUI [4,3])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Decompensated cirrhosis of liver Diagnostic radiologic examination | Decompensated cirrhosis of liver Biopsy | Decompensated cirrhosis of liver Clinical examination
Item
current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
boolean
C1619727 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C1619727 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C1619727 (UMLS CUI [3,1])
C1456356 (UMLS CUI [3,2])
Laboratory Results
Item
laboratory values:
boolean
C1254595 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
1. hemoglobin <12.0 g/dl (males) or <11.0 g/dl (females)
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Platelet Count measurement
Item
2. platelets <90,000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement | Exception Due to Gilbert Disease
Item
3. total serum bilirubin ≥2 mg/dl (unless due to gilbert's disease)
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])