ID

25028

Description

Visit 4 Subsequent Medical History and Laboratory Tests form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Keywords

Versions (1)
  1. 8/24/17 8/24/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 24, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Visit 4 Subsequent Medical History and Laboratory Tests Biologicals HepA/HepB vaccine 208127/125

English

Visit 4 Subsequent Medical History and Laboratory Tests Biologicals HepA/HepB vaccine 208127/125

1 forms  
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Protocol
Description

Protocol

Data type

text

Alias
UMLS CUI [1]
C1507394
Activity
Description

Activity

Data type

text

Alias
UMLS CUI [1]
C1512346
Date of activity
Description

day/month/year

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
SUBSEQUENT MEDICAL HISTORY
Description

SUBSEQUENT MEDICAL HISTORY

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0332282
Did the subject feel different in any way since the last visit or since the last assessment ?
Description

if Yes: Please complete the Adverse Experience Section

Data type

boolean

Alias
UMLS CUI [1,1]
C0443172
UMLS CUI [1,2]
C3714565
Has there been any change in medication since the last visit or in the previous 4 weeks, whichever is shorter ? (change includes a new medication, a stop in medication or a change in route / dose ... )
Description

if Yes: Please complete the Medication Section

Data type

boolean

Alias
UMLS CUI [1]
C2169461
LABORATORY TESTS
Description

LABORATORY TESTS

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken ?
Description

if Yes, see the SB Laboratory Results Report

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date of blood sampling :
Description

day/month/year

Data type

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Please comment :
Description

No blood sample taken

Data type

text

Alias
UMLS CUI [1]
C0005834
result anti-HAV
Description

Serology

Data type

integer

Alias
UMLS CUI [1]
C0201473
result anti-HBs
Description

Serology

Data type

integer

Alias
UMLS CUI [1]
C0201478
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Similar models

Visit 4 Subsequent Medical History and Laboratory Tests Biologicals HepA/HepB vaccine 208127/125

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Activity
Item
Activity
text
C1512346 (UMLS CUI [1])
Date of activity
Item
Date of activity
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
SUBSEQUENT MEDICAL HISTORY
C0262926 (UMLS CUI-1)
C0332282 (UMLS CUI-2)
Changed physical status
Item
Did the subject feel different in any way since the last visit or since the last assessment ?
boolean
C0443172 (UMLS CUI [1,1])
C3714565 (UMLS CUI [1,2])
Change in medication
Item
Has there been any change in medication since the last visit or in the previous 4 weeks, whichever is shorter ? (change includes a new medication, a stop in medication or a change in route / dose ... )
boolean
C2169461 (UMLS CUI [1])
Item Group
LABORATORY TESTS
C0022885 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
Date of blood sampling
Item
Date of blood sampling :
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
No blood sample taken
Item
Please comment :
text
C0005834 (UMLS CUI [1])
anti-HAV test
Item
result anti-HAV
integer
C0201473 (UMLS CUI [1])
anti-HBs test
Item
result anti-HBs
integer
C0201478 (UMLS CUI [1])
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