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ID

34844

Description

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 status of treatment blind form, study conclusion, pregnancy information, investigator's comment and signature. It has to be filled in for the end of study.

Keywords

Versions (3)
  1. 1/29/19 1/29/19 -
  2. 1/29/19 1/29/19 -
  3. 1/31/19 1/31/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 31, 2019

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License

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

    English

    Status of treatment blind, study conclusion, pregnancy information, investigator's comment and signature

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Status of treatment blind
    Description

    Status of treatment blind

    Alias
    UMLS CUI-1
    C0749659 (Treatment Status)
    UMLS CUI-2
    C2347038 (Blinded Clinical Study)
    Was the treatment blind broken during the study?
    Description

    If Yes, complete the following items.

    Data type

    text

    Alias
    UMLS CUI [1]
    C3897431 (Subject Unblinding Event Record)
    Date blind broken
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time blind broken
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Reason blind broken, tick one
    Description

    Complete Non-Serious Adverse Events, Serious Adverse Event and/or lnvestigational Product pages, as appropriate.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    If other reason blind broken, please specify
    Description

    Complete Non-Serious Adverse Events, Serious Adverse Event and/or lnvestigational Product pages, as appropriate.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Study conclusion
    Description

    Study conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    Date of subject completion or withdrawal
    Description

    day month year. If subject completed study: "Date of subject completion or withdrawal" must match the last scheduled study visit date. If subject withdrew and a withdrawal visit was conducted: "Date of subject completion or withdrawal" must match the date of subject withdrawal. If subject lost to follow-up: "Date of subject completion or withdrawal" must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject.

    Data type

    date

    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    Was the subject withdrawn from the study?
    Description

    Withdrawn from study

    Data type

    text

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    If subject was withdrawn from study, please tick the primary reason for withdrawl
    Description

    If you tick 1: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    If other reason for withdrawl, please specify
    Description

    Other reason for withdrawl

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    Pregnancy information
    Description

    Pregnancy information

    Alias
    UMLS CUI-1
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI-2
    C1533716 (Information)
    Did the subject become pregnant during the study?
    Description

    X: not of childbearing potential or male If you tick yes, complete Pregnancy Notification form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C3828490 (Pregnant During the Study)
    Investigator Comment Log
    Description

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961 (Clinical Investigators)
    UMLS CUI-2
    C0947611 (Comment)
    LOINC
    LP72293-1
    CRF page number if applicable
    Description

    CRF page number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704732 (Page (document))
    UMLS CUI [1,2]
    C1516308 (Case Report Form)
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Investigator's signature
    Description

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576 (Investigator Signature)
    Date of signature
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Investigator's signature
    Description

    "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."

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Investigator's name (print)
    Description

    Investigator's name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
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    Similar models

    Status of treatment blind, study conclusion, pregnancy information, investigator's comment and signature

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Status of treatment blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Item
    Was the treatment blind broken during the study?
    text
    C3897431 (UMLS CUI [1])
    Treatment blind broken
    Code List
    Was the treatment blind broken during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date blind broken
    Item
    Date blind broken
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time blind broken
    Item
    Time blind broken
    time
    C3897431 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Reason blind broken, tick one
    integer
    C3897431 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Reason blind broken
    Code List
    Reason blind broken, tick one
    CL Item
    Medical emergency requiring identification of investigational product for further treatment (1)
    CL Item
    Other (2)
    Item
    If other reason blind broken, please specify
    text
    C3897431 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Reason blind broken
    Code List
    If other reason blind broken, please specify
    Item Group
    Study conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    Item
    Was the subject withdrawn from the study?
    text
    C0422727 (UMLS CUI [1])
    Withdrawn from study
    Code List
    Was the subject withdrawn from the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If subject was withdrawn from study, please tick the primary reason for withdrawl
    integer
    C0422727 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Withdrawn from study
    Code List
    If subject was withdrawn from study, please tick the primary reason for withdrawl
    CL Item
    Adverse event (1)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from the study (4)
    CL Item
    Sponsor terminated study (5)
    CL Item
    Non-compliance (6)
    CL Item
    Other (7)
    Other reason for withdrawl
    Item
    If other reason for withdrawl, please specify
    text
    C0422727 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    Item Group
    Pregnancy information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did the subject become pregnant during the study?
    text
    C3828490 (UMLS CUI [1])
    Pregnancy during study
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not Applicable (X)
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    CRF page number
    Item
    CRF page number if applicable
    integer
    C1704732 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Investigator's name
    Item
    Investigator's name (print)
    text
    C2826892 (UMLS CUI [1])
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