ID

39684

Description

Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01838590

Link

https://clinicaltrials.gov/show/NCT01838590

Keywords

  1. 2/10/20 2/10/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2020

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.

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 Virus NCT01838590

Eligibility Hepatitis C Virus NCT01838590

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
treatment experienced and naïve subjects
Description

Therapy Experience | Therapy naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0596545
UMLS CUI [2]
C0919936
chronic genotype 4 hcv-infection
Description

Chronic Hepatitis C Genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
not co-infected with hiv
Description

HIV coinfection Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4062778
UMLS CUI [1,2]
C0332197
screening laboratory values within defined thresholds
Description

Laboratory Results Within Threshold

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C0449864
use of highly effective contraception methods
Description

Use of Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0700589
subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of any other clinically significant chronic liver disease
Description

Chronic liver disease Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0341439
UMLS CUI [1,2]
C0205394
pregnant or nursing female or male with pregnant female partner
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 of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Description

Illness Interferes with Therapeutic procedure | Illness Interferes with Assessment | Illness Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1516048
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
excessive alcohol ingestion or significant drug abuse
Description

Alcohol intake above recommended sensible limits | Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0560219
UMLS CUI [2]
C0013146

Similar models

Eligibility Hepatitis C Virus NCT01838590

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Therapy Experience | Therapy naive
Item
treatment experienced and naïve subjects
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2])
Chronic Hepatitis C Genotype
Item
chronic genotype 4 hcv-infection
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
HIV coinfection Absent
Item
not co-infected with hiv
boolean
C4062778 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Laboratory Results Within Threshold
Item
screening laboratory values within defined thresholds
boolean
C1254595 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C0449864 (UMLS CUI [1,3])
Use of Contraceptive methods
Item
use of highly effective contraception methods
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Protocol Compliance
Item
subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic liver disease Other
Item
history of any other clinically significant chronic liver disease
boolean
C0341439 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Gender Partner Pregnancy
Item
pregnant or nursing female or male with pregnant female partner
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
Illness Interferes with Therapeutic procedure | Illness Interferes with Assessment | Illness Interferes with Protocol Compliance
Item
history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Alcohol intake above recommended sensible limits | Drug abuse
Item
excessive alcohol ingestion or significant drug abuse
boolean
C0560219 (UMLS CUI [1])
C0013146 (UMLS CUI [2])

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

Fields marked with * are required.

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