Inglese

GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 11

1 moduli  
Informed consent
Descrizione

Informed consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Descrizione

I certify that Informed Consent has been obtained prior to any study procedure.

Tipo di dati

date

Alias
UMLS CUI [1]
C2985782
Demographics
Descrizione

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Descrizione

LONG-TERM FOLLOW-UP PREVIOUS STUDY 208127/106 (EXT HAB-084) – Month 60 Subject number will be the same as in the previous study.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Descrizione

Date of Birth

Tipo di dati

date

Alias
UMLS CUI [1]
C0421451
Gender
Descrizione

Gender

Tipo di dati

text

Alias
UMLS CUI [1]
C0079399
Laboratory Tests
Descrizione

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Descrizione

Blood sample taken for testing anti-HAV or anti-HBs

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0201473
UMLS CUI [2,1]
C1277698
UMLS CUI [2,2]
C0201478
Date blood sample was taken
Descrizione

Only answer if blood sample for testing anti-HAV or anti-HBs was taken and if the date the blood sample was taken is different from visit date.

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Descrizione

A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0170300
UMLS CUI [2]
C2240392
UMLS CUI [3]
C0593947
Tracking Document - Reason for non participation
Descrizione

Tracking Document - Reason for non participation

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C0392360
Previous subject number
Descrizione

Previous subject number

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Date of birth
Descrizione

Date of birth

Tipo di dati

date

Alias
UMLS CUI [1]
C0421451
Please document reason for non participation
Descrizione

reason for non participation

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392360
Subject not eligible? - please specify criteria that are not full-filled.
Descrizione

If you chose 'Subject not eligible' as reason for non participation, please specify.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C3828770
UMLS CUI [1,2]
C1521902
Subject eligible but not willing to participate due to:
Descrizione

Only, answer this question, if you chose 'Subject eligible but not willing to participate' as reason for non participation.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C3846156
UMLS CUI [1,2]
C0392360
Please specify 'adverse events or serious adverse event'.
Descrizione

If you chose 'adverse events or serious adverse event', please specify.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C1521902
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1521902
Please specify 'other'.
Descrizione

Please specify 'other' reason for eligible but not-willing to participate in study.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
Subject died on:
Descrizione

Please fill in Date of death, if you chose 'subject died on' as reason for non participation

Tipo di dati

date

Alias
UMLS CUI [1]
C1148348
Date of contact
Descrizione

Date of contact

Tipo di dati

date

Alias
UMLS CUI [1]
C0805839
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Similar models

GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 11

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed consent date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Blood sample taken for testing anti-HAV or anti-HBs
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C1277698 (UMLS CUI [1,1])
C0201473 (UMLS CUI [1,2])
C1277698 (UMLS CUI [2,1])
C0201478 (UMLS CUI [2,2])
Blood sample date
Item
Date blood sample was taken
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine
Item
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
boolean
C0170300 (UMLS CUI [1])
C2240392 (UMLS CUI [2])
C0593947 (UMLS CUI [3])
Item Group
Tracking Document - Reason for non participation
C2348568 (UMLS CUI-1)
C0392360 (UMLS CUI-2)
Previous subject number
Item
Previous subject number
text
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please document reason for non participation
integer
C2348568 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason for non participation
Code List
Please document reason for non participation
CL Item
Subject not eligible? - please specify criteria that are not full-filled: (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to: (3)
CL Item
Subject died on: (4)
subject not meeting criteria please specify
Item
Subject not eligible? - please specify criteria that are not full-filled.
text
C3828770 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Subject eligible but not willing to participate due to:
integer
C3846156 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Eligible but Refused due to
Code List
Subject eligible but not willing to participate due to:
CL Item
adverse events, or serious adverse event (1)
CL Item
other (2)
specify adverse events or serious adverse event
Item
Please specify 'adverse events or serious adverse event'.
text
C0559546 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
specify other reason
Item
Please specify 'other'.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Date of death
Item
Subject died on:
date
C1148348 (UMLS CUI [1])
Date of contact
Item
Date of contact
date
C0805839 (UMLS CUI [1])
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