ID

26183

Description

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

Keywords

Versions (1)
  1. 10/10/17 10/10/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 10, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

English

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

1 forms  
Non-Serious Adverse Event
Description

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?
Description

non-serious adverse event

Data type

boolean

Alias
UMLS CUI [1]
C1518404
AE No.
Description

AE No.

Data type

integer

Alias
UMLS CUI [1]
C0877248
Description:
Description

Adverse Event Description

Data type

text

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

Adverse Event Description

Data type

integer

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

Adverse Event Description

Data type

integer

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

Date Started

Data type

date

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

immediate postvaccination

Data type

boolean

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

End Date

Data type

date

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

Maximum Intensity

Data type

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?
Description

Relationship to investigational product

Data type

boolean

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

Outcome

Data type

integer

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

(Refer to protocol for full definition.)

Data type

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
Description

Refer to protocol for full definition.

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Back to the top of the page

Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial