ID

33814

Description

An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01281839

Link

https://clinicaltrials.gov/show/NCT01281839

Keywords

Versions (1)
  1. 12/28/18 12/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 28, 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 NCT01281839

English

Eligibility Hepatitis C NCT01281839

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
genotype 1 hepatitis c infection (confirmed at screening)
Description

Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0017431
have previously received peginterferon-based therapy for at least 24 weeks with documented hcv rna at last measurement and relapsed within 1 year of last taking medication
Description

PEGINTERFERON | Hepatitis C virus RNA Documented | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0982327
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C1301725
UMLS CUI [3]
C0277556
liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis c infection
Description

Chronic Hepatitis C Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0193388
must agree to use 2 forms of effective contraception throughout study (both males and females)
Description

Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
infection with hiv or non-genotype 1 hepatitis c
Description

HIV Infection | Hepatitis C Except Genotype 1

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C3532919
liver disease not related to hepatitic c infection
Description

Liver disease | Relationship Absent Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0019196
hepatic decompensation
Description

Hepatic decompensation

Data type

boolean

Alias
UMLS CUI [1]
C1394798
significant laboratory abnormalities or other active diseases
Description

Laboratory test result abnormal | Disease Other

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205394
pregnant or planning to become pregnant
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
Back to the top of the page

Similar models

Eligibility Hepatitis C NCT01281839

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C Genotype
Item
genotype 1 hepatitis c infection (confirmed at screening)
boolean
C0019196 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
PEGINTERFERON | Hepatitis C virus RNA Documented | Recurrent disease
Item
have previously received peginterferon-based therapy for at least 24 weeks with documented hcv rna at last measurement and relapsed within 1 year of last taking medication
boolean
C0982327 (UMLS CUI [1])
C0369335 (UMLS CUI [2,1])
C1301725 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
Chronic Hepatitis C Biopsy of liver
Item
liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis c infection
boolean
C0524910 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Contraceptive methods Quantity
Item
must agree to use 2 forms of effective contraception throughout study (both males and females)
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
HIV Infection | Hepatitis C Except Genotype 1
Item
infection with hiv or non-genotype 1 hepatitis c
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C3532919 (UMLS CUI [2,3])
Liver disease | Relationship Absent Hepatitis C
Item
liver disease not related to hepatitic c infection
boolean
C0023895 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019196 (UMLS CUI [2,3])
Hepatic decompensation
Item
hepatic decompensation
boolean
C1394798 (UMLS CUI [1])
Laboratory test result abnormal | Disease Other
Item
significant laboratory abnormalities or other active diseases
boolean
C0438215 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned
Item
pregnant or planning to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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