ID

23421

Description

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

Lien

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

Mots-clés

Versions (1)
  1. 04/07/2017 04/07/2017 -
Téléchargé le

4 juillet 2017

DOI

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Licence

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

Anglais

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

1 Formulaires  
Reason for non participation
Description

Reason for non participation

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

Previous Subject Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of birth
Description

Date of birth

Type de données

date

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

reason for non participation

Type de données

integer

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

Reason for non participation

Type de données

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:
Description

reason for non participation

Type de données

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:
Description

reason for non participation

Type de données

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:
Description

reason for non participation

Type de données

text

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

reason for non participation

Type de données

date

Alias
UMLS CUI [1]
C1148348
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0392360
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Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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