0 Ratings
ID

24616

Description

Study ID: 100470 Clinical Study ID: SCO100470 Study Title: A multicentre, randomised, double-blind, parallel group, 24 week study to compare the effect of salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via DISKUS®/ACCUHALER® inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Serevent Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (2)
  1. 8/8/17 8/8/17 -
  2. 8/8/17 8/8/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 8, 2017

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License

Creative Commons BY-NC 3.0
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    study conclusion events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    English

    study conclusion events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    subject identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    STUDY CONCLUSION
    Description

    STUDY CONCLUSION

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Date of subject completion or withdrawal.
    Description

    end of study

    Data type

    date

    Alias
    UMLS CUI [1]
    C2983670
    Was the subject withdrawn from the study?
    Description

    subject withdrawn from study

    Data type

    text

    Alias
    UMLS CUI [1]
    C0422727
    If "yes" to patient withdram from study, record the primary reason for withdrawal.
    Description

    patient withdrawn from study

    Data type

    text

    Alias
    UMLS CUI [1]
    C0422727
    MEDICAL DEVICE QUESTION
    Description

    MEDICAL DEVICE QUESTION

    Alias
    UMLS CUI-1
    C0025080
    Did the subject experience an incident or near-incident with GSK medical devices provided for use during this study?
    Description

    If Yes, complete the Medical Device Incident Report Form.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0025080
    UMLS CUI [1,2]
    C1551358
    PREGNANCY INFORMATION
    Description

    PREGNANCY INFORMATION

    Alias
    UMLS CUI-1
    C0032961
    Did the subject become pregnant during the study?
    Description

    If Yes, complete Pregnancy Notification form.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032961
    INVESTIGATOR COMMENT LOG
    Description

    INVESTIGATOR COMMENT LOG

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C0947611
    CRF page number if applicable
    Description

    page number of case report

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C1516308
    Comment
    Description

    investigator's comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0008961
    INVESTIGATOR’S SIGNATURE
    Description

    INVESTIGATOR’S SIGNATURE

    Alias
    UMLS CUI-1
    C2346576
    Investigator’s signature
    Description

    investigator's signature

    Data type

    text

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

    Investigator´s name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Description

    date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
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    Similar models

    study conclusion events salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    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
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    STUDY CONCLUSION
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    end of study
    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])
    subject withdrawn from study
    Code List
    Was the subject withdrawn from the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If "yes" to patient withdram from study, record the primary reason for withdrawal.
    text
    C0422727 (UMLS CUI [1])
    patient withdrawn from study
    Code List
    If "yes" to patient withdram from study, record the primary reason for withdrawal.
    CL Item
    Adverse event (1)
    CL Item
    Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. (Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from the study (4)
    CL Item
    Lack of efficacy (5)
    CL Item
    Exacerbation (14)
    CL Item
    Did not meet treatment elig bility criteria (24)
    CL Item
    Other, specify _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (Z)
    Item Group
    MEDICAL DEVICE QUESTION
    C0025080 (UMLS CUI-1)
    Item
    Did the subject experience an incident or near-incident with GSK medical devices provided for use during this study?
    text
    C0025080 (UMLS CUI [1,1])
    C1551358 (UMLS CUI [1,2])
    incident with medical devices
    Code List
    Did the subject experience an incident or near-incident with GSK medical devices provided for use during this study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    PREGNANCY INFORMATION
    C0032961 (UMLS CUI-1)
    Item
    Did the subject become pregnant during the study?
    text
    C0032961 (UMLS CUI [1])
    pregnancy
    Code List
    Did the subject become pregnant during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not Applicable (not of childbearing potential or male) (X)
    Item Group
    INVESTIGATOR COMMENT LOG
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    page number of case report
    Item
    CRF page number if applicable
    integer
    C1704732 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    investigator's comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Item Group
    INVESTIGATOR’S SIGNATURE
    C2346576 (UMLS CUI-1)
    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])
    date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Back to the top of the page 

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