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28295

Beschreibung

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Subject status and major events

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  4. 02.01.18 02.01.18 -
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GlaxoSmithKline

Hochgeladen am

2. Januar 2018

DOI

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    Subject status and major events GSK study Chronic Coronary Heart Disease NCT00799903

    Englisch

    Subject status and major events GSK study Chronic Coronary Heart Disease NCT00799903

    1 Formulare  
    Subject status and major events
    Beschreibung

    Subject status and major events

    1. Has the subject experienced a cardiac endpoint event (MI or UA requiring hospitalization) since the last visit?
    Beschreibung

    Yes - complete SAE and MI or ANG endpoint form

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1320716 (Cardiovascular event)
    SNOMED
    405617006
    2. Has the subject experienced a stroke / TIA event since the last visit?
    Beschreibung

    Yes - complete SAE and Stroke/TIA endpoint form

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3844446 (Stroke (CVA) or TIA)
    LOINC
    LA12362-2
    3. Has the subject been hospitalized for heart failure since the last visit?
    Beschreibung

    Yes - complete SAE and Hospitalisation for Heart Failure endpoint form

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [1,2]
    C0581377 (Decompensated cardiac failure)
    SNOMED
    195111005
    4. Has the subject undergone a coronary revascularisation since the last visit?
    Beschreibung

    Yes - complete SAE and Revascularisation endpoint form

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877341 (Coronary revascularisation)
    UMLS CUI [1,2]
    C1532338 (Percutaneous Coronary Intervention)
    SNOMED
    415070008
    5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
    Beschreibung

    Yes - complete SAE and Other Endpoint form

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1956346 (Coronary Artery Disease)
    SNOMED
    53741008
    UMLS CUI [1,2]
    C0151744 (Myocardial Ischemia)
    SNOMED
    414545008
    6. Has the subject undergone a non-coronary revascularisation since the last visit?
    Beschreibung

    Yes - complete SAE and Other Endpoint form

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877341 (Coronary revascularisation)
    UMLS CUI [1,2]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
    Beschreibung

    Yes - complete SAE and Other Endpoint form

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0002689 (Amputation of limb)
    SNOMED
    400053006
    8. Has the subject been diagnosed with new onset diabetes since the last visit?
    Beschreibung

    Yes - record details on New Onset Diabetes form, and the Non-Serious Adverse Event or Serious Adverse Event form, as appropriate

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0746890 (new onset)
    UMLS CUI [1,2]
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    9. Has the subject been diagnosed with new cancer, recurrence of an existing cancer, progression of cancer (=new metastases or new spread) or a benign gastrointestinal polyp(s)/neoplasm(s) since the last visit?
    Beschreibung

    Yes - record details on Cancer/GI Neoplasm/Polyp Report form and the Non-Serious Adverse Event or Serious Adverse Event form, as appropriate

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    10. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since the last time the form was updated?
    Beschreibung

    Yes - complete the GI procedures form. Note: If question is being asked for the first time please report GI endoscopic procedure(s) that have been performed from randomization visit until this visit. If question has already been answered at an earlier visit then only refer back to the last time this question was asked.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0282493 (Surgical Endoscopy)
    SNOMED
    264274002
    11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
    Beschreibung

    Yes - record details on the Cardiovascular Diagnostic Procedures form

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0430022 (diagnostic procedure)
    SNOMED
    103693007
    12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
    Beschreibung

    Yes - complete Serious Adverse Event form

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1519255 (Serious Adverse Event)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Subject status and major events GSK study Chronic Coronary Heart Disease NCT00799903

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Subject status and major events
    Item
    1. Has the subject experienced a cardiac endpoint event (MI or UA requiring hospitalization) since the last visit?
    text
    C1320716 (UMLS CUI [1])
    cardiac endpoint event
    Code List
    1. Has the subject experienced a cardiac endpoint event (MI or UA requiring hospitalization) since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    2. Has the subject experienced a stroke / TIA event since the last visit?
    text
    C3844446 (UMLS CUI [1])
    cardiac endpoint event
    Code List
    2. Has the subject experienced a stroke / TIA event since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    3. Has the subject been hospitalized for heart failure since the last visit?
    text
    C0019993 (UMLS CUI [1,1])
    C0581377 (UMLS CUI [1,2])
    cardiac endpoint event
    Code List
    3. Has the subject been hospitalized for heart failure since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    4. Has the subject undergone a coronary revascularisation since the last visit?
    text
    C0877341 (UMLS CUI [1,1])
    C1532338 (UMLS CUI [1,2])
    cardiac endpoint event
    Code List
    4. Has the subject undergone a coronary revascularisation since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
    text
    C1956346 (UMLS CUI [1,1])
    C0151744 (UMLS CUI [1,2])
    cardiac endpoint event
    Code List
    5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    6. Has the subject undergone a non-coronary revascularisation since the last visit?
    text
    C0877341 (UMLS CUI [1,1])
    C0543467 (UMLS CUI [1,2])
    cardiac endpoint event
    Code List
    6. Has the subject undergone a non-coronary revascularisation since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
    text
    C0002689 (UMLS CUI [1])
    cardiac endpoint event
    Code List
    7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    8. Has the subject been diagnosed with new onset diabetes since the last visit?
    text
    C0746890 (UMLS CUI [1,1])
    C0011849 (UMLS CUI [1,2])
    cardiac endpoint event
    Code List
    8. Has the subject been diagnosed with new onset diabetes since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    9. Has the subject been diagnosed with new cancer, recurrence of an existing cancer, progression of cancer (=new metastases or new spread) or a benign gastrointestinal polyp(s)/neoplasm(s) since the last visit?
    text
    C0006826 (UMLS CUI [1])
    cardiac endpoint event
    Code List
    9. Has the subject been diagnosed with new cancer, recurrence of an existing cancer, progression of cancer (=new metastases or new spread) or a benign gastrointestinal polyp(s)/neoplasm(s) since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    10. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since the last time the form was updated?
    text
    C0282493 (UMLS CUI [1])
    cardiac endpoint event
    Code List
    10. Has the subject had any GI endoscopic procedures (upper or lower) or GI capsule studies performed since the last time the form was updated?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
    text
    C0430022 (UMLS CUI [1])
    cardiac endpoint event
    Code List
    11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Item
    12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
    text
    C1519255 (UMLS CUI [1])
    cardiac endpoint event
    Code List
    12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Question not asked (Z)
    Zum Seitenanfang zurückkehren 

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