ID

26358

Description

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

Keywords

Versions (4)
  1. 10/12/17 10/12/17 -
  2. 10/16/17 10/16/17 -
  3. 10/23/17 10/23/17 -
  4. 1/2/18 1/2/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    Subject status and major events GSK study Chronic Coronary Heart Disease NCT00799903

    English

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

    1 forms  
    Subject status and major events
    Description

    Subject status and major events

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

    Yes - complete SAE and MI or ANG endpoint form

    Data type

    text

    2. Has the subject experienced a stroke / TIA event since the last visit?
    Description

    Yes - complete SAE and Stroke/TIA endpoint form

    Data type

    text

    3. Has the subject been hospitalized for heart failure since the last visit?
    Description

    Yes - complete SAE and Hospitalisation for Heart Failure endpoint form

    Data type

    text

    4. Has the subject undergone a coronary revascularisation since the last visit?
    Description

    Yes - complete SAE and Revascularisation endpoint form

    Data type

    text

    5. Has the subject been hospitalized for a non-coronary ischemic event since the last visit?
    Description

    Yes - complete SAE and Other Endpoint form

    Data type

    text

    6. Has the subject undergone a non-coronary revascularisation since the last visit?
    Description

    Yes - complete SAE and Other Endpoint form

    Data type

    text

    7. Has the subject undergone a limb amputation due to vascular cause since the last visit?
    Description

    Yes - complete SAE and Other Endpoint form

    Data type

    text

    8. Has the subject been diagnosed with new onset diabetes since the last visit?
    Description

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

    Data type

    text

    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?
    Description

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

    Data type

    text

    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?
    Description

    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.

    Data type

    text

    11. Were any cardiovascular diagnostic procedures that were related to endpoint events performed since the last visit?
    Description

    Yes - record details on the Cardiovascular Diagnostic Procedures form

    Data type

    text

    12. Since the last visit, did the subject experience SAE assessed as related to IP, study participation, or a GSK concomitant medication?
    Description

    Yes - complete Serious Adverse Event form

    Data type

    text

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    Similar models

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

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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)
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