ID

23907

Description

Study part: Extensive Swelling Report. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Keywords

Versions (1)
  1. 7/17/17 7/17/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 17, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Extensive Swelling Report Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

English

Extensive Swelling Report

1 forms  
EXTENSIVE SWELLING REPORT
Description

EXTENSIVE SWELLING REPORT

Alias
UMLS CUI-1
C0684224
UMLS CUI-2
C0038999
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Vaccine administered for which the extensive swelling is reported:
Description

vaccines

Data type

text

Alias
UMLS CUI [1]
C0042210
1. Date of physical examination
Description

Date of physical examination

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0031809
Was the examination performed by a member of study personnel during the extensive swelling period :
Description

Research Personnel; physical examination swelling

Data type

boolean

Alias
UMLS CUI [1]
C0035173
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0038999
2. Date when the swelling was first considered to be extensive:
Description

Date swelling

Data type

date

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

Swelling; Vaccination

Data type

text

Alias
UMLS CUI [1]
C0038999
UMLS CUI [2]
C0042196
3. Size of swelling:
Description

Measurement of the greatest diameter

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0456389
mm
4. Type of swelling:
Description

Type

Data type

text

Alias
UMLS CUI [1]
C0332307
5. Circumference of swollen limb (at the site of maximum swelling):
Description

Circumference Swelling limb

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C0015385
mm
5. Circumference of the opposite limb (at the same level):
Description

Circumference limb

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C1521805
mm
6. Associated signs: Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Route:
Description

Body temperature measurement site

Data type

integer

Alias
UMLS CUI [1]
C0489453
6. Associated signs: Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1]
C0332575
Largest diameter :
Description

diameter

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C1301886
mm
6. Associated signs: Induration
Description

Induration

Data type

boolean

Alias
UMLS CUI [1]
C0332534
Largest diameter :
Description

diameter

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C1301886
mm
6. Associated signs: Pain (at administration site)
Description

Pain

Data type

boolean

Alias
UMLS CUI [1]
C0030193
Intensity
Description

Intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
6. Associated signs: Functional impairment
Description

Functional impairment

Data type

boolean

Alias
UMLS CUI [1]
C4062321
Intensity
Description

Intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
7. 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) procedures and therapeutic interventions.
Description

Swelling Description; diagnostic procedure; therapeutic interventions.

Data type

text

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0678257
UMLS CUI [2]
C0430022
UMLS CUI [3]
C0808232
8. Last date when the swelling was still considered to be extensive:
Description

Last date swelling

Data type

date

Alias
UMLS CUI [1,1]
C3260033
UMLS CUI [1,2]
C0038999
If lasting for less than 24 hours, please specify duration (hours):
Description

Duration Swelling

Data type

integer

Measurement units
  • hours
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0038999
hours
9. Outcome of the swelling:
Description

Outcome swelling

Data type

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C0038999
10. Is there an alternative explanation for the swelling? (e.g. : allergy, infection, trauma, underlying conditions)
Description

causality allergy infection trauma

Data type

boolean

Alias
UMLS CUI [1,1]
C1314792
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0009450
UMLS CUI [1,4]
C3714660
If yes, please specify:
Description

Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
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Similar models

Extensive Swelling Report

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
EXTENSIVE SWELLING REPORT
C0684224 (UMLS CUI-1)
C0038999 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Vaccine administered for which the extensive swelling is reported:
text
C0042210 (UMLS CUI [1])
vaccines
Code List
Vaccine administered for which the extensive swelling is reported:
CL Item
Hib-MenCY OR Hib-MenC Vaccine [ 9 0 1 ] (1)
CL Item
MenC Vaccine [ 9 0 2 ] (2)
CL Item
DTPa-HBV-IPV Vaccine [ 1 4 ] (3)
CL Item
DTPa-HBV-IPV/Hib Vaccine [ 3 8 ] (4)
Date of physical examination
Item
1. Date of physical examination
date
C0011008 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Research Personnel; physical examination swelling
Item
Was the examination performed by a member of study personnel during the extensive swelling period :
boolean
C0035173 (UMLS CUI [1])
C0031809 (UMLS CUI [2,1])
C0038999 (UMLS CUI [2,2])
Date swelling
Item
2. Date when the swelling was first considered to be extensive:
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Swelling; Vaccination
Item
If occurring within 24 hours after vaccination, please specify how long after vaccination:
text
C0038999 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
Size
Item
3. Size of swelling:
float
C0456389 (UMLS CUI [1])
Item
4. Type of swelling:
text
C0332307 (UMLS CUI [1])
Type
Code List
4. Type of swelling:
CL Item
Local swelling around injection site, not involving adjacent joint (Local swelling around injection site, not involving adjacent joint)
CL Item
Diffuse swelling, not involving adjacent joint (Diffuse swelling, not involving adjacent joint)
CL Item
Swelling, involving adjacent joint (Swelling, involving adjacent joint)
Circumference Swelling limb
Item
5. Circumference of swollen limb (at the site of maximum swelling):
float
C0424682 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,3])
Circumference limb
Item
5. Circumference of the opposite limb (at the same level):
float
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
Temperature
Item
6. Associated signs: Temperature
float
C0039476 (UMLS CUI [1])
Item
Route:
integer
C0489453 (UMLS CUI [1])
body temperature
Code List
Route:
CL Item
Axillary [ A ] (1)
C0004454 (UMLS CUI-1)
(Comment:en)
CL Item
Rectal [ R ] (2)
C0205052 (UMLS CUI-1)
(Comment:en)
Redness
Item
6. Associated signs: Redness
boolean
C0332575 (UMLS CUI [1])
diameter
Item
Largest diameter :
integer
C1301886 (UMLS CUI [1])
Induration
Item
6. Associated signs: Induration
boolean
C0332534 (UMLS CUI [1])
diameter
Item
Largest diameter :
integer
C1301886 (UMLS CUI [1])
Pain
Item
6. Associated signs: Pain (at administration site)
boolean
C0030193 (UMLS CUI [1])
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
grade 1: Minor reaction to touch (1)
CL Item
grade 2: Cries / protests on touch (2)
CL Item
grade 3: Cries when limb is moved /spontaneously painful (3)
Functional impairment
Item
6. Associated signs: Functional impairment
boolean
C4062321 (UMLS CUI [1])
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
grade 1: easily tolerated, causing minimal discomfort and not interfering with everyday activities (1)
CL Item
grade 2: sufficiently discomforting to interfere with normal everyday activities (2)
CL Item
grade 3: prevents normal everyday activities (3)
Swelling Description; diagnostic procedure; therapeutic interventions.
Item
7. 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) procedures and therapeutic interventions.
text
C0038999 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0430022 (UMLS CUI [2])
C0808232 (UMLS CUI [3])
Last date swelling
Item
8. Last date when the swelling was still considered to be extensive:
date
C3260033 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Duration Swelling
Item
If lasting for less than 24 hours, please specify duration (hours):
integer
C0449238 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Item
9. Outcome of the swelling:
integer
C1705586 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Outcome swelling
Code List
9. Outcome of the swelling:
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
causality allergy infection trauma
Item
10. Is there an alternative explanation for the swelling? (e.g. : allergy, infection, trauma, underlying conditions)
boolean
C1314792 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C3714660 (UMLS CUI [1,4])
Specify
Item
If yes, please specify:
text
C1521902 (UMLS CUI [1])
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