ID

33821

Description

An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C); ODM derived from: https://clinicaltrials.gov/show/NCT01344889

Link

https://clinicaltrials.gov/show/NCT01344889

Keywords

  1. 1/2/19 1/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 2, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis C, Chronic NCT01344889

Eligibility Hepatitis C, Chronic NCT01344889

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients (according to local legislation)
Description

Adult

Data type

boolean

Alias
UMLS CUI [1]
C0001675
chronic hepatitis c
Description

Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0524910
treatment with long-acting interferon plus ribavirin
Description

Interferon Active Long-term | Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C3652465
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0443252
UMLS CUI [2]
C0035525
quantifiable hcv rna before initiation of treatment
Description

Hepatitis C RNA Quantification Test

Data type

boolean

Alias
UMLS CUI [1]
C1256156
no contra-indications to long-acting interferon and ribavirin therapy as detailed in the label
Description

Medical contraindication Absent Interferon | Interferon Active Long-term | Medical contraindication Absent Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C3652465
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0205177
UMLS CUI [2,3]
C0443252
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0035525
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
end stage renal disease
Description

Kidney Failure, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0022661
major organ transplantation
Description

Transplantation Organ Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0205164
concomitant therapy with telbivudine
Description

telbivudine

Data type

boolean

Alias
UMLS CUI [1]
C1453933
pregnant or breast-feeding females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
male partners of pregnant females
Description

Partner Male Pregnant female

Data type

boolean

Alias
UMLS CUI [1,1]
C0682323
UMLS CUI [1,2]
C0086582
UMLS CUI [1,3]
C0033011

Similar models

Eligibility Hepatitis C, Chronic NCT01344889

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult
Item
adult patients (according to local legislation)
boolean
C0001675 (UMLS CUI [1])
Hepatitis C, Chronic
Item
chronic hepatitis c
boolean
C0524910 (UMLS CUI [1])
Interferon Active Long-term | Ribavirin
Item
treatment with long-acting interferon plus ribavirin
boolean
C3652465 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C0035525 (UMLS CUI [2])
Hepatitis C RNA Quantification Test
Item
quantifiable hcv rna before initiation of treatment
boolean
C1256156 (UMLS CUI [1])
Medical contraindication Absent Interferon | Interferon Active Long-term | Medical contraindication Absent Ribavirin
Item
no contra-indications to long-acting interferon and ribavirin therapy as detailed in the label
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3652465 (UMLS CUI [1,3])
C3652465 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0443252 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Kidney Failure, Chronic
Item
end stage renal disease
boolean
C0022661 (UMLS CUI [1])
Transplantation Organ Major
Item
major organ transplantation
boolean
C0040732 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
telbivudine
Item
concomitant therapy with telbivudine
boolean
C1453933 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Partner Male Pregnant female
Item
male partners of pregnant females
boolean
C0682323 (UMLS CUI [1,1])
C0086582 (UMLS CUI [1,2])
C0033011 (UMLS CUI [1,3])

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