Informações: Esta não é a versão mais recente do modelo de dados. Uma visão geral da versão pode ser encontrada à esquerda em Versões. Para a versão mais recente, clique aqui.
Informações:
Falhas:
ID
25675
Descrição
Visit 2 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity Study ID: 100382 Clinical Study ID: 100382 Study Title: Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals’ Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289731 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Palavras-chave
Versões (3)
- 09/09/2017 09/09/2017 -
- 09/09/2017 09/09/2017 -
- 09/09/2017 09/09/2017 -
Transferido a
9 de setembro de 2017
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Visit 2 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity
Visit 2 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity
Similar models
Visit 2 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item
Did the subject come at visit 2?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
CL Item
Yes, please complete the following pages. (1)
CL Item
No, please complete below. (2)
Item
Please tick the ONE most appropriate reason.
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Other, please specify (OTH)
Number of SAE
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Other reason for non-participation
Item
Other, please specify
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Please tick who took the decision.
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator’s decision (1)
CL Item
Subject's decision (2)
Item
Has a urine sample been taken?
integer
C0200354 (UMLS CUI [1,1])
C1880076 (UMLS CUI [1,2])
C1880076 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (not of childbearing potential or male) (3)
Date of urine sample
Item
Date of urine sample
date
C2371162 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C0430056 (UMLS CUI [1,1])
C0427777 (UMLS CUI [1,2])
C0427777 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Pre-vaccination assessment
C0220825 (UMLS CUI-1)
C0005903 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0005903 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0449444 (UMLS CUI [1,2])
CL Item
Axillary (A)
CL Item
Oral (O)
Item Group
Vaccine administration - Twinrix group
C2368628 (UMLS CUI-1)
C0593953 (UMLS CUI-2)
C0593953 (UMLS CUI-2)
Date of vaccination
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,2])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,2])
CL Item
Twinrix Vaccine (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments vaccine administration
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
Item Group
Vaccine administration - Engerix-B and Havrix group
C2368628 (UMLS CUI-1)
C0116078 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
C0116078 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
Date of vaccination
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C0700881 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0700881 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0116078 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,2])
CL Item
Engerix-B Vaccine (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0700881 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,2])
CL Item
Havrix Vaccine (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments vaccine administration
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0700881 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0700881 (UMLS CUI [1,4])
Item Group
Vaccine administration - Hbvaxpro and Vaqta group
C2368628 (UMLS CUI-1)
C0379473 (UMLS CUI-2)
C1445761 (UMLS CUI-3)
C0379473 (UMLS CUI-2)
C1445761 (UMLS CUI-3)
Date of vaccination
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C0379473 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C0379473 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C1445761 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,2])
CL Item
HB VAX PRO (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0379473 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,2])
CL Item
Vaqta Vaccine (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments vaccine administration
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C1445761 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C1445761 (UMLS CUI [1,4])
Item Group
Vaccine administration - Vaccination 2
C2368628 (UMLS CUI-1)
C0474232 (UMLS CUI-2)
C0474232 (UMLS CUI-2)
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Other, please specify (OTH)
Number of SAE
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Other reason for non administration of vaccine
Item
Other, please specify
text
C2368628 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Please tick who took the decision
integer
C0679006 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
CL Item
Investigator (1)
CL Item
Subject (2)
Item Group
Serious adverse event - Post-vaccination observation
C1519255 (UMLS CUI-1)
C2368628 (UMLS CUI-2)
C0687676 (UMLS CUI-3)
C2368628 (UMLS CUI-2)
C0687676 (UMLS CUI-3)
Item
Has the subject experienced any serious adverse events within one month (minimum 30 days) post- vaccination?
text
C1519255 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Code List
Has the subject experienced any serious adverse events within one month (minimum 30 days) post- vaccination?
CL Item
Information not retrievable (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, fill in the Serious Adverse Event form. (Y)