0 Evaluaciones
ID

24571

Descripción

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

Palabras clave

Versiones (3)
  1. 6/8/17 6/8/17 -
  2. 8/8/17 8/8/17 -
  3. 8/8/17 8/8/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

6 de agosto de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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    concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    Inglés

    concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 formularios  
    COPD CONCOMITANT MEDICATIONS
    Descripción

    COPD CONCOMITANT MEDICATIONS

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    UMLS CUI-2
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
    Descripción

    COPD concomitant medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.
    Descripción

    If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    UMLS CUI-2
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    Drug Name
    Descripción

    Trade name preferred.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Unit Dose
    Descripción

    unit dose

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0869039 (Unit dose)
    SNOMED
    408102007
    Unit
    Descripción

    units of medication

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Frequency
    Descripción

    frequency of medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    Route
    Descripción

    medication routes

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Start Date
    Descripción

    start date of medication

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Taken prior to study?
    Descripción

    medication taken prior to study

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826667 (Concomitant Medication Previous Occurrence)
    Stop Date
    Descripción

    stop date of medication

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Ongoing medication?
    Descripción

    concomitant medication ongoing

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
    Was drug administered for an exacerbation?
    Descripción

    drug adminstered for a COPD exacerbation

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3469597 (Administration of medication)
    SNOMED
    18629005
    UMLS CUI [1,2]
    C0740304 (COPD exacerbation)
    NON-COPD CONCOMITANT MEDICATIONS
    Descripción

    NON-COPD CONCOMITANT MEDICATIONS

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Descripción

    medication that is not COPD-related

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.
    Descripción

    If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Drug name
    Descripción

    Trade name preferred.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Unit Dose
    Descripción

    unit dose

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0869039 (Unit dose)
    SNOMED
    408102007
    Unit
    Descripción

    units of medication

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Frequency
    Descripción

    frequency of medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    Route
    Descripción

    medication routes

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Reason for Medication
    Descripción

    reason for medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Start Date
    Descripción

    start date of medication

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Taken prior to study?
    Descripción

    medication taken prior to study

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826667 (Concomitant Medication Previous Occurrence)
    Stop Date
    Descripción

    stop date of medication

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Ongoing medication?
    Descripción

    concomitant medication ongoing

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
    Volver a la parte superior de la página

    Similar models

    concomitant medication salmeterol/fluticasone propionate combination compared to salmeterol on COPD 100470

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    COPD CONCOMITANT MEDICATIONS
    C2347852 (UMLS CUI-1)
    C0024117 (UMLS CUI-2)
    Item
    Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
    text
    C2347852 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    COPD concomitant medication
    Code List
    Were any COPD concomitant medications taken by the subject prior to screening and/or during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    If "yes" to COPD concomitant medication, record each medication separately by fulfilling the following items.
    C2347852 (UMLS CUI-1)
    C0024117 (UMLS CUI-2)
    medication name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    unit dose
    Item
    Unit Dose
    integer
    C0869039 (UMLS CUI [1])
    units of medication
    Item
    Unit
    integer
    C1519795 (UMLS CUI [1])
    frequency of medication
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    medication routes
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    start date of medication
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Taken prior to study?
    text
    C2826667 (UMLS CUI [1])
    medication taken prior to study
    Code List
    Taken prior to study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    stop date of medication
    Item
    Stop Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Ongoing medication?
    text
    C2826666 (UMLS CUI [1])
    concomitant medication ongoing
    Code List
    Ongoing medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was drug administered for an exacerbation?
    text
    C3469597 (UMLS CUI [1,1])
    C0740304 (UMLS CUI [1,2])
    drug adminstered for a COPD exacerbation
    Code List
    Was drug administered for an exacerbation?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    NON-COPD CONCOMITANT MEDICATIONS
    C2347852 (UMLS CUI-1)
    Item
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    text
    C2347852 (UMLS CUI [1])
    concomitant medication
    Code List
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    If "yes" to non-COPD concomitant medication, record each medication separately by fulfilling the following items.
    C2347852 (UMLS CUI-1)
    medication name
    Item
    Drug name
    text
    C2360065 (UMLS CUI [1])
    unit dose
    Item
    Unit Dose
    integer
    C0869039 (UMLS CUI [1])
    units of medication
    Item
    Unit
    integer
    C1519795 (UMLS CUI [1])
    frequency of medication
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    medication routes
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    reason for medication
    Item
    Reason for Medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    start date of medication
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Taken prior to study?
    text
    C2826667 (UMLS CUI [1])
    medication taken prior to study
    Code List
    Taken prior to study?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    stop date of medication
    Item
    Stop Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Ongoing medication?
    text
    C2826666 (UMLS CUI [1])
    concomitant medication ongoing
    Code List
    Ongoing medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Volver a la parte superior de la página 

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