Body mass index
Item
body mass index (bmi) of 18 to ≤ 37 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Hepatitis C, Chronic | Serology positive HCV | Hepatitis C virus RNA assay Peripheral blood
Item
clinical diagnosis of chronic hcv infection defined by positive serology for hcv for at least 6 months and detectable hcv rna in peripheral blood ≥105 iu/ml at screening
boolean
C0524910 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
C1272251 (UMLS CUI [3,1])
C0229664 (UMLS CUI [3,2])
Hepatitis C Genotype
Item
participant must be infected with hcv gt1a, gt1b, or gt 3
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Coinfection Genotype
Item
co-infection with gt1 and gt3
boolean
C0275524 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
estimated creatinine clearance of ≤70 ml/min based on the cockcroft-gault equation
boolean
C2711451 (UMLS CUI [1])
Cerebrovascular accident | Seizures chronic | Nervous system disorder Major
Item
history of stroke, chronic seizures, or major neurological disorder
boolean
C0038454 (UMLS CUI [1])
C0036572 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Endocrine System Diseases | Gastrointestinal Diseases | Exception Hepatitis C | Cardiovascular Diseases | Hematological Disease | Immune System Diseases | Kidney Diseases | Respiration Disorders | Disorder of the genitourinary system
Item
history of clinically significant endocrine, gastrointestinal (excepting hcv infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
boolean
C0014130 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
C0007222 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0021053 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0035204 (UMLS CUI [8])
C0080276 (UMLS CUI [9])
Neoplastic disease
Item
history of neoplastic disease
boolean
C1882062 (UMLS CUI [1])
Hepatitis B surface antigen positive
Item
positive hepatitis b surface antigen at the pre-study (screening) visit
boolean
C0149709 (UMLS CUI [1])
Major surgery | Blood Donation Amount | Blood Loss Amount | Study Subject Participation Status | Research study
Item
has had major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
boolean
C0679637 (UMLS CUI [1])
C0005794 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3163616 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4])
C0681814 (UMLS CUI [5])
NS5A Inhibitor
Item
previous treatments (s) with nonstructural protein 5a (ns5a) inhibitors
boolean
C3883357 (UMLS CUI [1])
Protease Inhibitors Investigational Recent
Item
<4 weeks since administration of any experimental protease inhibitor
boolean
C0033607 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Exposure to Interferon-alpha | Exposure to Ribavirin
Item
previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of elbasvir in the study
boolean
C0332157 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
Liver disease Advanced | Decompensated liver disease
Item
clinical or laboratory evidence of advanced or decompensated liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2])