Information:
Fel:
ID
39683
Beskrivning
Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT01713283
Länk
https://clinicaltrials.gov/show/NCT01713283
Nyckelord
Versioner (1)
- 2020-02-10 2020-02-10 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
10 februari 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Eligibility Hepatitis C Virus NCT01713283
Eligibility Hepatitis C Virus NCT01713283
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis C Virus NCT01713283
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Egyptian Generation First
Item
first generation egyptian; must have been born in egypt and can trace both maternal and paternal egyptian ancestry
boolean
C0337801 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0079411 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
Therapy Experience | Therapy naive
Item
treatment-experienced or treatment-naive
boolean
C0087111 (UMLS CUI [1,1])
C0596545 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2])
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])
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])
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])
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])
C0700589 (UMLS CUI [1,2])
Protocol Compliance
Item
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])
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])
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])
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 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])
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])
C0013146 (UMLS CUI [2])