ID

26183

Beschrijving

Study ID: 101223 Clinical Study ID: 101223 Study Title: Study to assess the lot-to-lot consistency of the production method of GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine and to compare to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine, when administered as a primary vaccination course. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Non-Serious Adverse Events

Trefwoorden

Versies (1)
  1. 10-10-17 10-10-17 -
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GlaxoSmithKline

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10 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine Non-Serious Adverse Events 101223

Engels

Non-Serious Adverse Events GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 Formulieren  
Non-Serious Adverse Event
Beschrijving

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C2240392
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschrijving

non-serious adverse event

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
AE No.
Beschrijving

AE No.

Datatype

integer

Alias
UMLS CUI [1]
C0877248
Description:
Beschrijving

Adverse Event Description

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
Adverse Event Description
Beschrijving

Adverse Event Description

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
Administration site
Beschrijving

Adverse Event Description

Datatype

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Date Started:
Beschrijving

Date Started

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
during immediate postvaccination period (30 minutes)
Beschrijving

immediate postvaccination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231291
UMLS CUI [1,2]
C0877248
Date Stopped:
Beschrijving

End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Intensity:
Beschrijving

Maximum Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Relationship to investigational product

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1518404
Outcome:
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Medically attended visit:
Beschrijving

(Refer to protocol for full definition.)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medically attended visit. If yes please specify type
Beschrijving

Refer to protocol for full definition.

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
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Similar models

Non-Serious Adverse Events GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
C2240392 (UMLS CUI-2)
non-serious adverse event
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1])
AE No.
Item
AE No.
integer
C0877248 (UMLS CUI [1])
Adverse Event Description
Item
Description:
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Adverse Event Description
integer
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Adverse Event Description
Code List
Adverse Event Description
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Item
Administration site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration site
Code List
Administration site
CL Item
DTPw-HBV/Hib Kft vaccine (1)
CL Item
Tritanrix-HepB/Hiberix vaccine (2)
CL Item
Triple Antigen vaccine (3)
CL Item
Hiberix vaccine (4)
Date Started
Item
Date Started:
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
immediate postvaccination
Item
during immediate postvaccination period (30 minutes)
boolean
C0231291 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
End Date
Item
Date Stopped:
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity:
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Maximum Intensity:
Code List
Maximum Intensity:
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Outcome:
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome:
Code List
Outcome:
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)
Medically attended visit
Item
Medically attended visit:
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Medically attended visit. If yes please specify type
integer
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended visit:
Code List
Medically attended visit. If yes please specify type
CL Item
Hospitalisation (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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