ID

29244

Description

Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

Keywords

Versions (1)
  1. 3/11/18 3/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 11, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Infanrix Vaccine - 102038

English

Visit 2

1 forms  
  1. StudyEvent: ODM
    1. Visit 2
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Center
Description

Center ID

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Description

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject come at visit 2?
Description

Study Continuation

Data type

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0042210
Did the subject not come at visit 2?
Description

Please tick the ONE most appropriate reason and skip the following forms belonging to this Visit

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
If SAE, please specify SAE N°
Description

Serious Adverse Event form

Data type

integer

Alias
UMLS CUI [1]
C1519255
If AEX, please specify AE N° (Unsol.) or code (Solicited)
Description

Non-Serious adverse event (complete the Non-serious Adverse Event section).

Data type

integer

Alias
UMLS CUI [1]
C1518404
If other, please specify
Description

(e.g.: consent withdrawal, Protocol violation,…)

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C1272696
Who took the decision?
Description

took decision

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1548562
Laboratory Tests
Description

Laboratory Tests

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

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date of blood sample only if different from visit date
Description

date of blood sample

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Similar models

Visit 2

1 forms
  1. StudyEvent: ODM
    1. Visit 2
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Center ID
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Study Continuation
Item
Did the subject come at visit 2?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Did the subject not come at visit 2?
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason Vaccine not administered
Code List
Did the subject not come at visit 2?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
C1519255 (UMLS CUI-1)
(Comment:en)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
C1518404 (UMLS CUI-1)
(Comment:en)
CL Item
Other, please specify (OTH)
C0205394 (UMLS CUI-1)
C2368628 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
C1272696 (UMLS CUI-4)
(Comment:en)
Serious adverse event
Item
If SAE, please specify SAE N°
integer
C1519255 (UMLS CUI [1])
Non-serious adverse event
Item
If AEX, please specify AE N° (Unsol.) or code (Solicited)
integer
C1518404 (UMLS CUI [1])
Other reason for non-administration
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
Item
Who took the decision?
text
C0679006 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1548562 (UMLS CUI [1,3])
took decision
Code List
Who took the decision?
CL Item
Investigator (I)
C0008961 (UMLS CUI-1)
(Comment:en)
CL Item
Parents/Guardians (P)
C0030551 (UMLS CUI-1)
C0023226 (UMLS CUI-3)
(Comment:en)
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 sample
Item
Date of blood sample only if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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