ID

32260

Description

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains the large swelling reaction form. It's only for "immuno and reacto subset" and has to be filled in if a large swelling reaction is confirmed during study. It's only for workbook 1 and 2.

Lien

https://clinicaltrials.gov/ct2/show/NCT00466947

Mots-clés

Versions (2)
  1. 25/10/2018 25/10/2018 -
  2. 26/10/2018 26/10/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

25 octobre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Vaccination against pneumonia and otitis media 109563, NCT00466947

Anglais

Large swelling reaction

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of large swelling reaction
Description

Date of large swelling reaction

Type de données

date

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0443286
UMLS CUI [1,3]
C0011008
Workbook number
Description

Workbook number

Type de données

integer

Alias
UMLS CUI [1]
C2986015
Case number
Description

Case number

Type de données

integer

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Vaccines, large swelling reaction
Description

Vaccines, large swelling reaction

Alias
UMLS CUI-1
C0038999
UMLS CUI-2
C0443286
UMLS CUI-3
C0042210
Vaccine administered for which the large swelling reaction reported:
Description

Vaccines, large swelling reaction

Type de données

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0443286
UMLS CUI [1,4]
C0042210
LARGE SWELLING REACTION
Description

LARGE SWELLING REACTION

Alias
UMLS CUI-1
C0038999
UMLS CUI-2
C0443286
UMLS CUI-3
C0031809
Date of physical examination
Description

Date of physical examination

Type de données

date

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

Examination performed by study member during large swelling reaction period

Type de données

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C0443286
UMLS CUI [1,4]
C1550483
Date when the swelling was first considered to be a large swelling reaction
Description

First recognition of swelling

Type de données

date

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1511790
UMLS CUI [1,4]
C0011008
If occurring within 24 hours after vaccination, please specify how long after vaccination
Description

Occuring after vaccination

Type de données

integer

Unités de mesure
  • h
Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
h
Size of swelling
Description

Measurement of the greatest diameter

Type de données

float

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Type of swelling
Description

Please specify in section 7

Type de données

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0332307
Circumference of swollen limb
Description

at the site of maximum swelling

Type de données

float

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C0038999
mm
Circumference of the opposite limb
Description

at the same level

Type de données

float

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C1521805
mm
Associated signs: Temperature measurement
Description

Associated signs: Temperature measurement

Type de données

float

Unités de mesure
  • °C
Alias
UMLS CUI [1]
C0886414
°C
Route of temperature measurement
Description

Route of temperature measurement

Type de données

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Associated signs: Redness
Description

Associated signs: Redness

Type de données

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0332575
Associated signs: Induration
Description

Associated signs: Induration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0332534
Associated signs: Pain
Description

Associated signs: Pain

Type de données

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0030193
Associated signs: functional impairment
Description

Associated signs: functional impairment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C4062321
Size of Redness
Description

largest diameter

Type de données

float

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
mm
Size of induration
Description

largest diameter

Type de données

float

Unités de mesure
  • mm
Alias
UMLS CUI [1,1]
C0332534
UMLS CUI [1,2]
C2700396
mm
Intensity of pain at injection site
Description

Intensity of pain at injection site is defined as: grade 1: Minor reaction to touch grade 2: Cries / protests on touch grade 3: Cries when limb is moved /spontaneously painful

Type de données

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C2700396
Intensity of functional impairment
Description

Intensity of functional impairment is defined as: Grade 1: Easily tolerated, causing minimal discomfort and not interfering with everyday activities Grade 2: Sufficiently discomforting to interfere with normal everyday activities Grade 3: Prevents normal everyday activities

Type de données

integer

Alias
UMLS CUI [1,1]
C4062321
UMLS CUI [1,2]
C0518690
Clinical case description and outcome of the adverse event
Description

Clinical case description and outcome of the adverse event

Alias
UMLS CUI-1
C0678257
UMLS CUI-2
C0205210
UMLS CUI-3
C0868928
UMLS CUI-4
C1705586
Case description
Description

Please give a clinical description of the observed large swelling reaction, including a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions. Originally with drawing of a child's body where you can fill in examination results.

Type de données

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0868928
Last date when the swelling was still considered to be large swelling reaction
Description

Last date when swelling was still considered to be large swelling reaction

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C0443286
If lasting for less than 24 hours, please specify duration (hours)
Description

Lasting for less than 24 hours

Type de données

integer

Unités de mesure
  • h
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0449238
h
Outcome of the large swelling reaction
Description

If you tick 3 please provide further follow-up data. If you tick 4 please specify under section 7

Type de données

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C0038999
Is there an alternative explanation for the swelling?
Description

e.g.: allergy, infection, trauma, underlying conditions

Type de données

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0681841
UMLS CUI [1,3]
C1523987
If there is an alternative explanation for the swelling please specify
Description

Alternative explanation for swelling, specification

Type de données

text

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0681841
UMLS CUI [1,3]
C1523987
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Similar models

Large swelling reaction

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of large swelling reaction
Item
Date of large swelling reaction
date
C0038999 (UMLS CUI [1,1])
C0443286 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
workbook 1 (1)
CL Item
workbook 2 (2)
Case number
Item
integer
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Vaccines, large swelling reaction
C0038999 (UMLS CUI-1)
C0443286 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Vaccine administered for which the large swelling reaction reported:
integer
C0038999 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0443286 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
undefined item
Code List
Vaccine administered for which the large swelling reaction reported:
CL Item
10Pn-PD-DiT Vaccine or HAV Vaccine (1)
CL Item
DTPa-IPV/Hib Vaccine (2)
Item Group
LARGE SWELLING REACTION
C0038999 (UMLS CUI-1)
C0443286 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Date of physical examination
Item
Date of physical examination
date
C0031809 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Examination performed by study member during large swelling reaction period
Item
Was the examination performed by a member of study personnel during the large swelling reaction period
boolean
C0031809 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0443286 (UMLS CUI [1,3])
C1550483 (UMLS CUI [1,4])
First recognition of swelling
Item
Date when the swelling was first considered to be a large swelling reaction
date
C0038999 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1511790 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Occuring after vaccination
Item
If occurring within 24 hours after vaccination, please specify how long after vaccination
integer
C2745955 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Size of swelling
Item
Size of swelling
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
Type of swelling
integer
C0038999 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of swelling
Code List
Type of swelling
CL Item
Local swelling around injection site, not involving adjacent joint (1)
CL Item
Diffuse swelling, not involving adjacent joint (2)
CL Item
Swelling, involving adjacent joint (3)
Circumference of swollen limb
Item
Circumference of swollen limb
float
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Circumference of the opposite limb
Item
Circumference of the opposite limb
float
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
Associated signs: Temperature measurement
Item
Associated signs: Temperature measurement
float
C0886414 (UMLS CUI [1])
Item
Route of temperature measurement
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Route of temperature measurement
Code List
Route of temperature measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Associated signs: Redness
Item
Associated signs: Redness
boolean
C0037088 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Associated signs: Induration
Item
Associated signs: Induration
boolean
C0037088 (UMLS CUI [1,1])
C0332534 (UMLS CUI [1,2])
Associated signs: Pain
Item
Associated signs: Pain
boolean
C0037088 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Associated signs: functional impairment
Item
Associated signs: functional impairment
boolean
C0037088 (UMLS CUI [1,1])
C4062321 (UMLS CUI [1,2])
Size of Redness
Item
Size of Redness
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of induration
Item
Size of induration
float
C0332534 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Intensity of pain at injection site
integer
C1320357 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Intensity of pain at injection site
Code List
Intensity of pain at injection site
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
Item
Intensity of functional impairment
integer
C4062321 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of functional impairment
Code List
Intensity of functional impairment
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
Item Group
Clinical case description and outcome of the adverse event
C0678257 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
C0868928 (UMLS CUI-3)
C1705586 (UMLS CUI-4)
Case description
Item
Case description
text
C0678257 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0868928 (UMLS CUI [1,3])
Last date when swelling was still considered to be large swelling reaction
Item
Last date when the swelling was still considered to be large swelling reaction
date
C0806020 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C0443286 (UMLS CUI [1,3])
Lasting for less than 24 hours
Item
If lasting for less than 24 hours, please specify duration (hours)
integer
C0038999 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
Outcome of the large swelling reaction
integer
C1705586 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Outcome of the large swelling reaction
Code List
Outcome of the large swelling reaction
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)
Alternative explanation for swelling
Item
Is there an alternative explanation for the swelling?
boolean
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C1523987 (UMLS CUI [1,3])
Alternative explanation for swelling, specification
Item
If there is an alternative explanation for the swelling please specify
text
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C1523987 (UMLS CUI [1,3])
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