ID

36615

Beschrijving

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Trefwoorden

Versies (1)
  1. 26-05-19 26-05-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

26 mei 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

Engels

Non-Serious Adverse Events

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Beschrijving

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
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, Administration of vaccine, Post

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
AE No.
Beschrijving

Non-serious Adverse Event, Numbers

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description
Beschrijving

Non-serious Adverse Event, Description

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Location
Beschrijving

Non-serious Adverse Event, Location

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0450429
Date Started
Beschrijving

Non-serious Adverse Event, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Date Stopped
Beschrijving

Non-serious Adverse Event, End Date

Datatype

date

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

Non-serious Adverse Event, Severity of Adverse Event

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Non-serious Adverse Event, Relationships, Experimental drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Outcome
Beschrijving

Non-serious Adverse Event, Adverse Event Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Medically attended visit (Refer to protocol for full definition.)
Beschrijving

Non-serious Adverse Event, Visit, Advice, Medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
Beschrijving

Non-serious Adverse Event, Visit, Advice, Medical, Type

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0332307
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Similar models

Non-Serious Adverse Events

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious Adverse Event, Administration of vaccine, Post
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
C1519255 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Item
AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serios Adverse Event, Numbers
Code List
AE No.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Non-serious Adverse Event, Description
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Location
text
C1518404 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Non-serious Adverse Event, Location
Code List
Location
CL Item
Administration site (1)
CL Item
Non-administration site (2)
Non-serious Adverse Event, Start Date
Item
Date Started
date
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Non-serious Adverse Event, End Date
Item
Date Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum Intensity
text
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Non-serious Adverse Event, Severity of Adverse Event
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Non-serious Adverse Event, Relationships, Experimental drug
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event 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)
Non-serious Adverse Event, Visit, Advice, Medical
Item
Medically attended visit (Refer to protocol for full definition.)
boolean
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Non-serious Adverse Event, Visit, Advice, Medical, Type
Item
If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
text
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
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