Informações:
Falhas:
ID
14146
Descrição
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years; ODM derived from: https://clinicaltrials.gov/show/NCT00383383
Link
https://clinicaltrials.gov/show/NCT00383383
Palavras-chave
Versões (1)
- 31/03/2016 31/03/2016 -
Transferido a
31 de março de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00383383
Eligibility Hepatitis B NCT00383383
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT00383383
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Gender and age at the first vaccination
Item
a male or female > = 15 years of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0419726 (UMLS CUI [2,2])
C0001779 (UMLS CUI [2,1])
C0419726 (UMLS CUI [2,2])
Written informed consent
Item
written informed consent obtained from the subject/ from the parents or guardians of the subject.
boolean
C0021430 (UMLS CUI [1])
Anti-hbs antibodies, anti-hbc antibodies & hepatitis b surface antigen
Item
seronegative for anti-hbs antibodies, anti-hbc antibodies & hepatitis b surface antigen (hbsag).
boolean
C0201478 (UMLS CUI [1])
C0201480 (UMLS CUI [2])
C0201477 (UMLS CUI [3])
C0201480 (UMLS CUI [2])
C0201477 (UMLS CUI [3])
Gynaecological status
Item
if the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
Pre-haemodialysis or haemodialysis
Item
pre-haemodialysis patient* or a patient on haemodialysis.
boolean
C1264634 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
C0019004 (UMLS CUI [2])
Experimental drug
Item
use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
boolean
C0304229 (UMLS CUI [1])
Hepatitis b vaccination
Item
previous vaccination against hepatitis b.
boolean
C0474232 (UMLS CUI [1])
Hepatitis b infection
Item
history of hepatitis b infection.
boolean
C0019163 (UMLS CUI [1])
HBV exposure
Item
known exposure to hepatitis b virus within 6 weeks. pregnant or lactating female
boolean
C0019169 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,2])
Alt/ast values
Item
clinically abnormal alt/ast values (> 3 times normal values)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201899 (UMLS CUI [2])