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35986

Descrição

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

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Versões (1)
  1. 08/04/2019 08/04/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

8 de abril de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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    Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718

    Inglês

    Long-Term Follow Up (Year 11) - Follow-Up Studies; Study Conclusion

    1 Formulários  
    Administrative
    Descrição

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Descrição

    Subject number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Follow-Up Studies
    Descrição

    Follow-Up Studies

    Alias
    UMLS CUI-1
    C0016441
    If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
    Descrição

    If No, please specify the most appropriate reason

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0016441
    UMLS CUI [1,2]
    C0600109
    If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
    Descrição

    If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0016441
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [1,3]
    C0392360
    If Adverse Event or Serious Adverse Event, please specify
    Descrição

    If Adverse Event or Serious Adverse Event, please specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C2348235
    If other, please specify
    Descrição

    If other, please specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    Study Conclusion
    Descrição

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
    Descrição

    If Yes, specify total number of SAE's

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C2347804
    UMLS CUI [3]
    C2348563
    Total number of SAE's
    Descrição

    Total number of SAE's

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Did the subject become pregnant before the end of the study?
    Descrição

    If Yes, complete the Pregnancy notification form.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0032961
    Was the subject withdrawn from the study?
    Descrição

    If Yes, record major reason for withdrawal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Major reason for withdrawal
    Descrição

    Tick one box only

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    If Serious adverse event, please specify SAE No
    Descrição

    Please complete and submit SAE report

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    If Non-serious adverse event, please specify AE No or solicited AE code.
    Descrição

    Please complete Non-serious Adverse Event section

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [2,1]
    C1518404
    UMLS CUI [2,2]
    C0805701
    If protocol violation, please specify
    Descrição

    If protocol violation, please specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1709750
    UMLS CUI [1,2]
    C2348235
    If other reason, please specify
    Descrição

    If other reason, please specify

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C2348235
    Who made the decision?
    Descrição

    Who made the decision?

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0679006
    Date of last contact
    Descrição

    Date of last contact

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0805839
    Was the subject in good condition at date of last contact?
    Descrição

    If No, please give details in Adverse Events section.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1142435
    UMLS CUI [1,2]
    C0681850
    Investigator signature
    Descrição

    Investigator signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator Signature
    Descrição

    I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator Signature Date
    Descrição

    Investigator Signature Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Investigator name
    Descrição

    Investigator name

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826892
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    Similar models

    Long-Term Follow Up (Year 11) - Follow-Up Studies; Study Conclusion

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Follow-Up Studies
    C0016441 (UMLS CUI-1)
    If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
    Item
    If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
    boolean
    C0016441 (UMLS CUI [1,1])
    C0600109 (UMLS CUI [1,2])
    Item
    If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
    integer
    C0016441 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    If subject would not be willing to participate in a follow-up study, please specify the reason
    Code List
    If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
    CL Item
    Adverse Events, or Serious Adverse Events (1)
    CL Item
    Other (2)
    If Adverse Event or Serious Adverse Event, please specify
    Item
    If Adverse Event or Serious Adverse Event, please specify
    text
    C0877248 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    If other, please specify
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
    Item
    Did the subject experience any Serious Adverse Event during the study period as specified in the protocol?
    boolean
    C1519255 (UMLS CUI [1])
    C2347804 (UMLS CUI [2])
    C2348563 (UMLS CUI [3])
    Total number of SAE's
    Item
    Total number of SAE's
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item
    Did the subject become pregnant before the end of the study?
    text
    C0032961 (UMLS CUI [1])
    Did the subject become pregnant before the end of the study?
    Code List
    Did the subject become pregnant before the end of the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    CL Item
    Not Applicable (not of childbearing potential or male) (N/A)
    Was the subject withdrawn from the study?
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    Major reason for withdrawal
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Major reason for withdrawal
    Code List
    Major reason for withdrawal
    CL Item
    Serious adverse event  (SAE)
    CL Item
    Non-Serious adverse event  (AEX)
    CL Item
    Protocol violation, please specify (PTV)
    CL Item
    Consent withdrawal, not due to an adverse event.  (CWS)
    CL Item
    Migrated / moved from the study area  (MIG)
    CL Item
    Lost to follow-up (LFU)
    CL Item
    Other, please specify (OTH)
    If Serious adverse event, please specify SAE No
    Item
    If Serious adverse event, please specify SAE No
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    If Non-serious adverse event, please specify AE No or solicited AE code.
    Item
    If Non-serious adverse event, please specify AE No or solicited AE code.
    text
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [2,1])
    C0805701 (UMLS CUI [2,2])
    If protocol violation, please specify
    Item
    If protocol violation, please specify
    text
    C1709750 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    If other reason, please specify
    Item
    If other reason, please specify
    text
    C3840932 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item
    Who made the decision?
    text
    C0679006 (UMLS CUI [1])
    Who made the decision?
    Code List
    Who made the decision?
    CL Item
    Investigator (I)
    CL Item
    Parents/ Guardians (P)
    Date of last contact
    Item
    Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Was the subject in good condition at date of last contact?
    Item
    Was the subject in good condition at date of last contact?
    boolean
    C1142435 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    Item Group
    Investigator signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Investigator Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature Date
    Item
    Investigator Signature Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator name
    Item
    Investigator name
    text
    C2826892 (UMLS CUI [1])
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