ID

23907

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-07-17 2017-07-17 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 juli 2017

DOI

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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

Engelsk

Extensive Swelling Report

1 Formulär  
EXTENSIVE SWELLING REPORT
Beskrivning

EXTENSIVE SWELLING REPORT

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

Subject number

Datatyp

integer

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

vaccines

Datatyp

text

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

Date of physical examination

Datatyp

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 :
Beskrivning

Research Personnel; physical examination swelling

Datatyp

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:
Beskrivning

Date swelling

Datatyp

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:
Beskrivning

Swelling; Vaccination

Datatyp

text

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

Measurement of the greatest diameter

Datatyp

float

Måttenheter
  • mm
Alias
UMLS CUI [1]
C0456389
mm
4. Type of swelling:
Beskrivning

Type

Datatyp

text

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

Circumference Swelling limb

Datatyp

float

Måttenheter
  • 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):
Beskrivning

Circumference limb

Datatyp

float

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

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Route:
Beskrivning

Body temperature measurement site

Datatyp

integer

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

Redness

Datatyp

boolean

Alias
UMLS CUI [1]
C0332575
Largest diameter :
Beskrivning

diameter

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1]
C1301886
mm
6. Associated signs: Induration
Beskrivning

Induration

Datatyp

boolean

Alias
UMLS CUI [1]
C0332534
Largest diameter :
Beskrivning

diameter

Datatyp

integer

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

Pain

Datatyp

boolean

Alias
UMLS CUI [1]
C0030193
Intensity
Beskrivning

Intensity

Datatyp

integer

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

Functional impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C4062321
Intensity
Beskrivning

Intensity

Datatyp

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.
Beskrivning

Swelling Description; diagnostic procedure; therapeutic interventions.

Datatyp

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:
Beskrivning

Last date swelling

Datatyp

date

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

Duration Swelling

Datatyp

integer

Måttenheter
  • hours
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0038999
hours
9. Outcome of the swelling:
Beskrivning

Outcome swelling

Datatyp

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)
Beskrivning

causality allergy infection trauma

Datatyp

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:
Beskrivning

Specify

Datatyp

text

Alias
UMLS CUI [1]
C1521902
Tillbaka till toppen

Similar models

Extensive Swelling Report

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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