ID

28998

Description

A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.

Keywords

Versions (1)
  1. 2/20/18 2/20/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 20, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) Study ID: 101518

English

Swelling assessment No.2

2 forms  
Report of physical examination and case clinical description
Description

Report of physical examination and case clinical description

Alias
UMLS CUI-1
C0031809
Date of physical examination
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Was the examination performed by a member of study personnel during the extensive swelling period :
Description

Examiner

Data type

boolean

Alias
UMLS CUI [1]
C0025082
Date when the swelling was first considered to be extensive:
Description

Date of first extensive swelling

Data type

date

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0205231
UMLS CUI [1,4]
C0011008
If occurring within 24 hours after vaccination, please specify how long after vaccination:
Description

Date of fist extensive swelling

Data type

integer

Measurement units
  • hours
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C2700396
UMLS CUI [1,3]
C0205231
UMLS CUI [1,4]
C0011008
hours
Please give a clinical description of the observed extensive swelling, including a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s)
Description

Swelling case description

Data type

text

Alias
UMLS CUI [1,1]
C0449437
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C0038999
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Similar models

Swelling assessment No.2

2 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Date
Item
Date of physical examination
date
C0011008 (UMLS CUI [1])
Examiner
Item
Was the examination performed by a member of study personnel during the extensive swelling period :
boolean
C0025082 (UMLS CUI [1])
Date of first extensive swelling
Item
Date when the swelling was first considered to be extensive:
date
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0205231 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Date of fist extensive swelling
Item
If occurring within 24 hours after vaccination, please specify how long after vaccination:
integer
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0205231 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Swelling case description
Item
Please give a clinical description of the observed extensive swelling, including a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s)
text
C0449437 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
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