ID

29745

Description

A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin); ODM derived from: https://clinicaltrials.gov/show/NCT01429792

Link

https://clinicaltrials.gov/show/NCT01429792

Keywords

Versions (2)
  1. 4/18/18 4/18/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 18, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis C, Chronic NCT01429792

English

Eligibility Hepatitis C, Chronic NCT01429792

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
serologic evidence of chronic hepatitis c, genotype 1, 2, 3 or 4 by anti-hcv antibody test
Description

Chronic Hepatitis C HCV genotype determination | Hepatitis C antibody, confirmatory test

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2]
C0373853
documented pre-treatment hcv rna quantitative result
Description

Serum hepatitis c viral rna quantitative pre treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C4272238
UMLS CUI [1,2]
C2709094
compensated liver disease (child-pugh grade a)
Description

Compensated liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C3839044
UMLS CUI [1,2]
C2347612
patient receiving standard combination treatment of pegasys (peginterferon alfa-2a and copegus (ribavirin)
Description

Combined Modality Therapy | Pegasys | Peginterferon alfa-2a | Copegus | Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0009429
UMLS CUI [2]
C1176430
UMLS CUI [3]
C0391001
UMLS CUI [4]
C1170183
UMLS CUI [5]
C0035525
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
decompensated liver disease (child-pugh class b or c cirrhosis)
Description

Decompensated liver disease Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C2347612
co-infection with active hepatitis a and/or hepatitis b
Description

HAV Coinfection | HBV coinfection

Data type

boolean

Alias
UMLS CUI [1,1]
C0376325
UMLS CUI [1,2]
C0275524
UMLS CUI [2]
C2242656
history or evidence of a medical condition associated with liver disease other than hcv
Description

Medical condition Associated with Liver disease | Exception Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
signs and symptoms of hepatocellular carcinoma
Description

Signs and Symptoms Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C2239176
history of poorly controlled thyroid disease, elevated tsh or any clinical manifestations of thyroid disease
Description

Thyroid Disease Poorly controlled | Elevated TSH | Manifestation Clinical Thyroid Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C1855743
UMLS CUI [3,1]
C0205319
UMLS CUI [3,2]
C0205210
UMLS CUI [3,3]
C0040128
therapy with antineoplastic treatment </= 6 months prior to study day
Description

Antineoplastic Drug/Agent Therapy

Data type

boolean

Alias
UMLS CUI [1]
C2346834
diabetes mellitus in subjects receiving an insulin therapy
Description

Insulin regime Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011849
evidence of severe retinopathy
Description

Retinal Diseases Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205082
pregnant or breast-feeding women, and 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
Back to the top of the page

Similar models

Eligibility Hepatitis C, Chronic NCT01429792

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Hepatitis C HCV genotype determination | Hepatitis C antibody, confirmatory test
Item
serologic evidence of chronic hepatitis c, genotype 1, 2, 3 or 4 by anti-hcv antibody test
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0373853 (UMLS CUI [2])
Serum hepatitis c viral rna quantitative pre treatment
Item
documented pre-treatment hcv rna quantitative result
boolean
C4272238 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
Compensated liver disease Child-Pugh Classification
Item
compensated liver disease (child-pugh grade a)
boolean
C3839044 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
Combined Modality Therapy | Pegasys | Peginterferon alfa-2a | Copegus | Ribavirin
Item
patient receiving standard combination treatment of pegasys (peginterferon alfa-2a and copegus (ribavirin)
boolean
C0009429 (UMLS CUI [1])
C1176430 (UMLS CUI [2])
C0391001 (UMLS CUI [3])
C1170183 (UMLS CUI [4])
C0035525 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Decompensated liver disease Child-Pugh Classification
Item
decompensated liver disease (child-pugh class b or c cirrhosis)
boolean
C4075847 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
HAV Coinfection | HBV coinfection
Item
co-infection with active hepatitis a and/or hepatitis b
boolean
C0376325 (UMLS CUI [1,1])
C0275524 (UMLS CUI [1,2])
C2242656 (UMLS CUI [2])
Medical condition Associated with Liver disease | Exception Hepatitis C
Item
history or evidence of a medical condition associated with liver disease other than hcv
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Signs and Symptoms Liver carcinoma
Item
signs and symptoms of hepatocellular carcinoma
boolean
C0037088 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
Thyroid Disease Poorly controlled | Elevated TSH | Manifestation Clinical Thyroid Disease
Item
history of poorly controlled thyroid disease, elevated tsh or any clinical manifestations of thyroid disease
boolean
C0040128 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C1855743 (UMLS CUI [2])
C0205319 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0040128 (UMLS CUI [3,3])
Antineoplastic Drug/Agent Therapy
Item
therapy with antineoplastic treatment </= 6 months prior to study day
boolean
C2346834 (UMLS CUI [1])
Insulin regime Diabetes Mellitus
Item
diabetes mellitus in subjects receiving an insulin therapy
boolean
C0557978 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Retinal Diseases Severe
Item
evidence of severe retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnant or breast-feeding women, and 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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial