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ID

34860

Beschreibung

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the PGx-Pharmacogenetic research form. It has to be filled in for the end of study.

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Versionen (2)
  1. 31.01.19 31.01.19 -
  2. 01.02.19 01.02.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

1. Februar 2019

DOI

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Creative Commons BY-NC 3.0
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    Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

    Englisch

    PGx-Pharmacogenetic research

    1 Formulare  
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of Assessment
    Beschreibung

    Date of Assessment

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    PGx-Pharmacogenetic research consent
    Beschreibung

    PGx-Pharmacogenetic research consent

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C2347500
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Beschreibung

    Consent for PGx-Pharmacogenetic research

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If informed consent been obtained for PGx-Pharmacogenetic research, record the date informed consent obtained for PGx-Pharmacogenetic research
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2347500
    Reason for non consent for PGx-Pharmacogenetic research
    Beschreibung

    tick one reason

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2347500
    UMLS CUI [1,4]
    C0566251
    If other reason for non consent for PGx-Pharmacogenetic research, please specify
    Beschreibung

    Other reason for non consent for PGx-Pharmacogenetic research

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2347500
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C0566251
    Blood sample collection (DNA)
    Beschreibung

    Blood sample collection (DNA)

    Alias
    UMLS CUI-1
    C0005834
    UMLS CUI-2
    C2347500
    Has a blood sample been collected for PGx-pharmacogenetic research?
    Beschreibung

    Blood sample collected for PGx-pharmacogenetic research

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C2347500
    Date of blood sample collected for PGx-pharmacogenetic research
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C2347500
    Withdrawal of consent
    Beschreibung

    Withdrawal of consent

    Alias
    UMLS CUI-1
    C1707492
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Beschreibung

    This question must be completed immediately if the subject withdraws consent. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom informed consent was obtained for PGx-Pharmacogenetic research.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C1707492
    Blood sample destruction
    Beschreibung

    Blood sample destruction

    Alias
    UMLS CUI-1
    C1948029
    UMLS CUI-2
    C0178913
    Has a request been made for sample destruction?
    Beschreibung

    This question must be completed immediately if there is a request for sample destruction. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom a blood sample was obtained for PGx-Pharmacogenetic research.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    Reason for request for sample destruction
    Beschreibung

    Tick one reason

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C1272683
    UMLS CUI [1,3]
    C1948029
    UMLS CUI [1,4]
    C0178913
    If other reason for request for sample destruction, please specify
    Beschreibung

    Other reason for request for sample destruction

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C1948029
    UMLS CUI [1,5]
    C0178913
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    PGx-Pharmacogenetic research

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item Group
    PGx-Pharmacogenetic research consent
    C0021430 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Item
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Consent for PGx-Pharmacogenetic research
    Code List
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of consent for PGx-Pharmacogenetic research
    Item
    If informed consent been obtained for PGx-Pharmacogenetic research, record the date informed consent obtained for PGx-Pharmacogenetic research
    date
    C0011008 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2347500 (UMLS CUI [1,3])
    Item
    Reason for non consent for PGx-Pharmacogenetic research
    integer
    C1298908 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2347500 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    Reason for request for sample destruction
    Code List
    Reason for non consent for PGx-Pharmacogenetic research
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other (3)
    Other reason for non consent for PGx-Pharmacogenetic research
    Item
    If other reason for non consent for PGx-Pharmacogenetic research, please specify
    text
    C1298908 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2347500 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C0566251 (UMLS CUI [1,5])
    Item Group
    Blood sample collection (DNA)
    C0005834 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Item
    Has a blood sample been collected for PGx-pharmacogenetic research?
    text
    C0005834 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Route, medication
    Code List
    Has a blood sample been collected for PGx-pharmacogenetic research?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of blood sample collected for PGx-pharmacogenetic research
    Item
    Date of blood sample collected for PGx-pharmacogenetic research
    date
    C0011008 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C2347500 (UMLS CUI [1,3])
    Item Group
    Withdrawal of consent
    C1707492 (UMLS CUI-1)
    Item
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    text
    C2347500 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    Ongoing medication
    Code List
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Blood sample destruction
    C1948029 (UMLS CUI-1)
    C0178913 (UMLS CUI-2)
    Item
    Has a request been made for sample destruction?
    text
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    Request for sample destruction
    Code List
    Has a request been made for sample destruction?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Reason for request for sample destruction
    text
    C0566251 (UMLS CUI [1,1])
    C1272683 (UMLS CUI [1,2])
    C1948029 (UMLS CUI [1,3])
    C0178913 (UMLS CUI [1,4])
    Concomitant medication taken
    Code List
    Reason for request for sample destruction
    CL Item
    Subject requested (1)
    CL Item
    Other (2)
    Other reason for request for sample destruction
    Item
    If other reason for request for sample destruction, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C1948029 (UMLS CUI [1,4])
    C0178913 (UMLS CUI [1,5])
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