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Eligibility Hepatitis C, Chronic NCT01483742

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, 18 to 65 years of age inclusive
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
chronic hepatitis c, genotype 1 or 4
Description

Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
cohort 1: treatment-naïve for hepatitis c
Description

Therapy naive Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0019196
cohort 2: prior null responder to treatment with approved doses of pegylated interferon plus ribavirin
Description

Therapy non-responder | PEGINTERFERON/RIBAVIRIN Dose Approved

Data type

boolean

Alias
UMLS CUI [1]
C0919875
UMLS CUI [2,1]
C1875630
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205540
liver biopsy confirming cirrhosis
Description

Liver Cirrhosis Confirmed by Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0521093
UMLS CUI [1,3]
C0193388
compensated cirrhosis (child-pugh a)
Description

Compensated cirrhosis Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1608426
UMLS CUI [1,2]
C4050412
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women or male partners of women who are pregnant
Description

Pregnancy | Breast Feeding | Gender Partner Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
history or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)
Description

Decompensated liver disease | Ascites | Hepatic Encephalopathy | Liver carcinoma | Bleeding esophageal varices

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0019151
UMLS CUI [4]
C2239176
UMLS CUI [5]
C0155789
cohort 2: patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response
Description

PEGINTERFERON/RIBAVIRIN Discontinued | Etiology Except Therapy non-responder

Data type

boolean

Alias
UMLS CUI [1,1]
C1875630
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0919875
history of clinically significant cardiovascular or cerebrovascular disease
Description

Cardiovascular Disease | Cerebrovascular Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0007820
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Similar models

Eligibility Hepatitis C, Chronic NCT01483742

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, 18 to 65 years of age inclusive
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hepatitis C Genotype
Item
chronic hepatitis c, genotype 1 or 4
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive Hepatitis C
Item
cohort 1: treatment-naïve for hepatitis c
boolean
C0919936 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Therapy non-responder | PEGINTERFERON/RIBAVIRIN Dose Approved
Item
cohort 2: prior null responder to treatment with approved doses of pegylated interferon plus ribavirin
boolean
C0919875 (UMLS CUI [1])
C1875630 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205540 (UMLS CUI [2,3])
Liver Cirrhosis Confirmed by Biopsy of liver
Item
liver biopsy confirming cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Compensated cirrhosis Child-Pugh Classification
Item
compensated cirrhosis (child-pugh a)
boolean
C1608426 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnant or lactating women or male partners of women who are pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
Decompensated liver disease | Ascites | Hepatic Encephalopathy | Liver carcinoma | Bleeding esophageal varices
Item
history or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)
boolean
C4075847 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0019151 (UMLS CUI [3])
C2239176 (UMLS CUI [4])
C0155789 (UMLS CUI [5])
PEGINTERFERON/RIBAVIRIN Discontinued | Etiology Except Therapy non-responder
Item
cohort 2: patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response
boolean
C1875630 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0919875 (UMLS CUI [2,3])
Cardiovascular Disease | Cerebrovascular Disorder
Item
history of clinically significant cardiovascular or cerebrovascular disease
boolean
C0007222 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
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