ID

33815

Descripción

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01289782

Link

https://clinicaltrials.gov/show/NCT01289782

Palabras clave

  1. 28/12/18 28/12/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

28 de diciembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Hepatitis C NCT01289782

Eligibility Hepatitis C NCT01289782

Inclusion Criteria
Descripción

Inclusion Criteria

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

Hepatitis C Genotype

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0017431
patient has not received any prior treatment for hepatitis c
Descripción

Did not receive therapy for Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332155
UMLS CUI [1,2]
C0019196
patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis c infection
Descripción

Chronic Hepatitis C Biopsy of liver

Tipo de datos

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)
Descripción

Agreement Contraceptive methods Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Descripción

Exclusion Criteria

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

HIV Infection | Hepatitis C Except Genotype 1

Tipo de datos

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
Descripción

Liver disease | Relationship Absent Hepatitis C

Tipo de datos

boolean

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

Hepatic decompensation

Tipo de datos

boolean

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

Laboratory test result abnormal | Disease Other

Tipo de datos

boolean

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

Pregnancy | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992

Similar models

Eligibility Hepatitis C NCT01289782

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Did not receive therapy for Hepatitis C
Item
patient has not received any prior treatment for hepatitis c
boolean
C0332155 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Chronic Hepatitis C Biopsy of liver
Item
patient must have had a 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])
Agreement Contraceptive methods Quantity
Item
must agree to use 2 forms of effective contraception throughout study (both males and females)
boolean
C0680240 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
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])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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