ID

23895

Descripción

Study part: Check for Study Continuation Visit 2. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Palabras clave

Versiones (1)
  1. 16/7/17 16/7/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

16 de julio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Check for Study Continuation Visit 2 Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

Inglés

Check for Study Continuation Visit 2

1 formularios  
CHECK FOR STUDY CONTINUATION
Descripción

CHECK FOR STUDY CONTINUATION

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Did the subject come at visit 2 ?
Descripción

visit

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0545082
If no, (SAE) Serious adverse event (complete the Serious Adverse Event form)?
Descripción

SAE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Please specify SAE N° :
Descripción

SAE

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
If no, (AEX) Non-Serious adverse event (complete the Non-serious Adverse Event page)?
Descripción

Non-Serious adverse event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518404
Please specify AE N° (Unsol.) or code (Solicited) :
Descripción

Non-Serious adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C1518404
(OTH) Other, please specify :
Descripción

(e.g. : consent withdrawal, Protocol violation, …)

Tipo de datos

text

Alias
UMLS CUI [1]
C0205394
Investigator's decision
Descripción

Investigator desicion study discontinuation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C2826233
Parents/Guardian’s decision
Descripción

Parents desicion study discontinuation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C2826233
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Similar models

Check for Study Continuation Visit 2

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
CHECK FOR STUDY CONTINUATION
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
visit
Item
Did the subject come at visit 2 ?
boolean
C0545082 (UMLS CUI [1])
SAE
Item
If no, (SAE) Serious adverse event (complete the Serious Adverse Event form)?
boolean
C1519255 (UMLS CUI [1])
SAE
Item
Please specify SAE N° :
text
C1519255 (UMLS CUI [1])
Non-Serious adverse event
Item
If no, (AEX) Non-Serious adverse event (complete the Non-serious Adverse Event page)?
boolean
C1518404 (UMLS CUI [1])
Non-Serious adverse event
Item
Please specify AE N° (Unsol.) or code (Solicited) :
text
C1518404 (UMLS CUI [1])
other
Item
(OTH) Other, please specify :
text
C0205394 (UMLS CUI [1])
Investigator desicion study discontinuation
Item
Investigator's decision
boolean
C0008961 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C2826233 (UMLS CUI [1,3])
Parents desicion study discontinuation
Item
Parents/Guardian’s decision
boolean
C0030551 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C2826233 (UMLS CUI [1,3])
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