ID

23421

Descrição

Clinical Study ID: 100450 Study Title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins (HBIg) in newborns of HBeAg+ mothers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00240526 https://clinicaltrials.gov/ct2/show/NCT00240526 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B Documentation part: Tracking Document, Reason for non participation

Link

https://clinicaltrials.gov/ct2/show/NCT00240526

Palavras-chave

Versões (1)
  1. 04/07/2017 04/07/2017 -
Transferido a

4 de julho de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins Reason for non participation NCT00240526

Inglês

Reason for non participation Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins NCT00240526

1 Formulários  
Reason for non participation
Descrição

Reason for non participation

Alias
UMLS CUI-1
C0679823
UMLS CUI-2
C0392360
UMLS CUI-3
C0016441
UMLS CUI-4
C0474232
Previous Subject Number
Descrição

Previous Subject Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Date of birth
Descrição

Date of birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Please document reason for non participation
Descrição

reason for non participation

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0392360
Please specify eligibility criteria that are not fullfilled
Descrição

Reason for non participation

Tipo de dados

text

Alias
UMLS CUI [1]
C1516637
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0392360
Subject eligible but not willing to participate due to:
Descrição

reason for non participation

Tipo de dados

integer

Alias
UMLS CUI [1]
C0558080
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0392360
Subject eligible but not willing to participate due to: adverse events, or serious adverse event. Please specify:
Descrição

reason for non participation

Tipo de dados

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0392360
Subject eligible but not willing to participate due to: Other. Please specify:
Descrição

reason for non participation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0392360
Subject died on:
Descrição

reason for non participation

Tipo de dados

date

Alias
UMLS CUI [1]
C1148348
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0392360
Voltar ao início da página

Similar models

Reason for non participation Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins NCT00240526

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Reason for non participation
C0679823 (UMLS CUI-1)
C0392360 (UMLS CUI-2)
C0016441 (UMLS CUI-3)
C0474232 (UMLS CUI-4)
Previous Subject Number
Item
Previous Subject Number
text
C2348585 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please document reason for non participation
integer
C0679823 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason for non participation
Code List
Please document reason for non participation
CL Item
Subject not eligible?  (1)
CL Item
Subject lost to follow-up or not reached  (2)
CL Item
Subject eligible but not willing to participate (3)
CL Item
Subject died (4)
reason for non participation
Item
Please specify eligibility criteria that are not fullfilled
text
C1516637 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
Item
Subject eligible but not willing to participate due to:
integer
C0558080 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
reason for non participation
Code List
Subject eligible but not willing to participate due to:
CL Item
Adverse events, or serious adverse event (1)
CL Item
Other (2)
reason for non participation
Item
Subject eligible but not willing to participate due to: adverse events, or serious adverse event. Please specify:
text
C0877248 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
reason for non participation
Item
Subject eligible but not willing to participate due to: Other. Please specify:
text
C0679823 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
subject died
Item
Subject died on:
date
C1148348 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
Voltar ao início da página 

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