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ID

28324

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: Endpoint Stroke/TIA - Repeating form (Scheduled visits)

Keywords

Versions (6)
  1. 10/6/17 10/6/17 -
  2. 10/6/17 10/6/17 -
  3. 10/16/17 10/16/17 -
  4. 10/23/17 10/23/17 -
  5. 1/3/18 1/3/18 -
  6. 1/4/18 1/4/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 4, 2018

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Creative Commons BY-NC 3.0
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    Endpoint Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

    English

    Endpoint Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

    1 forms  
    Investigator Section
    Description

    Investigator Section

    1. Date of onset of symptoms
    Description

    Date of onset of symptoms

    Data type

    date

    Alias
    UMLS CUI [1]
    C0574845
    1. Time of onset of symptoms
    Description

    Time of onset of symptoms

    Data type

    time

    Alias
    UMLS CUI [1]
    C0449244
    2. Date of of symptom resolution
    Description

    Date of of symptom resolution

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985918
    2. Time of of symptom resolution
    Description

    Time of of symptom resolution

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826658
    3. Event
    Description

    Event

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0877248
    4. Symptoms: [B01] Motor and/or sensory loss in face,arm,leg
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3176213
    4. Symptoms: [B02] Dysphasia/aphasia (difficulty with language)
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0973461
    4. Symptoms: [B03] Dysarthria/dysphagia (difficulty with speech and swallowing)
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011168
    UMLS CUI [1,2]
    C0013362
    4. Symptoms: [B04] Hemianopsia
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018979
    4. Symptoms: [B05] Dizziness/vertigo
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042571
    4. Symptoms: [B06] Ataxia
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004134
    4. Symptoms: [B07] Nystagmus
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0028738
    4. Symptoms: [B08] Diplopia
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0012569
    4. Symptoms: [B09] Acute confusion/cognitive change
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009676
    4. Symptoms: [B10] Decreased consciousness
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0517960
    5. Did the subject have a new focal neurologic deficit thought to be of vascular origin, with signs or symptoms lasting >24 hours?
    Description

    new focal neurologic deficit

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0746857
    5. If neurologic symptoms <24 hours, was new brain lesion confirmed by diffusion-weighted MRI showing the presence of a new brain infarct?
    Description

    new brain infarct

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0333559
    6. Did neuro-imaging show an ischemic defect matching the clinical symptoms?
    Description

    ischemic defect neuro-imaging

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027853
    7. Method of diagnosis: [B11] Neurological exam
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027853
    7. Method of diagnosis: [B12] Neuro-ophthalmologic exam (retinal embolism, infarction)
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027853
    7. Method of diagnosis: [B13] CT scan
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0040405
    7. Method of diagnosis: [B14] MRI scan
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0917711
    7. Method of diagnosis: [B15] Invasive angiography
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085532
    7. Method of diagnosis: [B16] Autopsy
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004398
    UMLS CUI [1,2]
    C0243095
    UMLS CUI [1,3]
    C0011900
    7. Method of diagnosis: [OT] Other
    Description

    Check all that apply

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2911685
    8. Was there a change in the modified Rankin Scale grade?
    Description

    change in modified Rankin Scale grade

    Data type

    text

    Alias
    UMLS CUI [1]
    C2984908
    8. Most recent pre-event modified Rankin Scale grade
    Description

    Most recent pre-event modified Rankin Scale grade

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2984908
    8. Date of most recent pre-event modified Rankin Scale grade
    Description

    Date of most recent pre-event modified Rankin Scale grade

    Data type

    date

    Alias
    UMLS CUI [1]
    C2984908
    8. Latest post-event modified Rankin Scale grade
    Description

    Latest post-event modified Rankin Scale grade

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2984908
    8. Date of latest post-event modified Rankin Scale grade
    Description

    Date of latest post-event modified Rankin Scale grade

    Data type

    date

    Alias
    UMLS CUI [1]
    C2984908
    9. Type of stroke
    Description

    Type of stroke

    Data type

    text

    Alias
    UMLS CUI [1]
    C3897486
    10. Provide narrative
    Description

    narrative

    Data type

    text

    Alias
    UMLS CUI [1]
    C1135957
    11. Date documents sent to CEC Document Group
    Description

    Date documents sent to CEC Document Group

    Data type

    date

    CEC Section
    Description

    CEC Section

    8. Adjudication
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C0680730
    If non-fatal stroke, select one
    Description

    non-fatal stroke

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0038454
    If type of non-fatal stroke uncertain, comment
    Description

    Non-fatal stroke type uncertain

    Data type

    text

    If fatal stroke, select one
    Description

    fatal stroke

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0038454
    If type of fatal stroke uncertain, comment
    Description

    Fatal stroke, type uncertain

    Data type

    text

    Alias
    UMLS CUI [1]
    C0393963
    Does not meet criteria for stroke, comment
    Description

    criteria for stroke not met, comment

    Data type

    text

    If criteria for stroke are not met, selet one
    Description

    criteria for stroke not met

    Data type

    text

    If other, please comment
    Description

    If criteria for stroke not met

    Data type

    text

    15. Date of adjudication
    Description

    [hidden]

    Data type

    date

    Alias
    UMLS CUI [1]
    C3260278
    CEC STATUS
    Description

    CEC STATUS

    16. Trigger number
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C1444748
    17. CEC Status
    Description

    [read-only]

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0449438
    18. Date of status change
    Description

    [read-only]

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0443172
    19. Physician review #1: Physician
    Description

    [hidden]

    Data type

    integer

    19. Physician review #1: Date sent to reviewer
    Description

    [hidden]

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1515022
    UMLS CUI [1,2]
    C0011008
    19. Physician review #1: Date received from reviewer
    Description

    [hidden]

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    19. Physician review #2: Physician
    Description

    [hidden]

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3166277
    19. Physician review #2: Date sent to reviewer
    Description

    [hidden]

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1515023
    UMLS CUI [1,2]
    C0011008
    19. Physician review #2: Date received from reviewer
    Description

    [hidden]

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3166277
    UMLS CUI [1,2]
    C0011008
    21. CEC Coordinator comments
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1710220
    UMLS CUI [1,2]
    C0282411
    22. CV event number
    Description

    [hidden]

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826275
    23. Adverse event reference identifier
    Description

    Use SAE Sequence number from the corresponding SAE form (the last item on the form, in the "Non- Clinical" section) [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2348585
    24. Adverse event term
    Description

    Copy Serious Adverse Event term from corresponding SAE form [hidden]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1516728
    UMLS CUI [1,2]
    C2826934
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    Similar models

    Endpoint Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Investigator Section
    Date of onset of symptoms
    Item
    1. Date of onset of symptoms
    date
    C0574845 (UMLS CUI [1])
    Time of onset of symptoms
    Item
    1. Time of onset of symptoms
    time
    C0449244 (UMLS CUI [1])
    Date of of symptom resolution
    Item
    2. Date of of symptom resolution
    date
    C2985918 (UMLS CUI [1])
    Time of of symptom resolution
    Item
    2. Time of of symptom resolution
    time
    C2826658 (UMLS CUI [1])
    Item
    3. Event
    integer
    C0877248 (UMLS CUI [1])
    Event
    Code List
    3. Event
    CL Item
    Non-fatal stroke (44)
    CL Item
    Fatal stroke (45)
    CL Item
    TIA (6)
    Symptoms Motor and/or sensory loss
    Item
    4. Symptoms: [B01] Motor and/or sensory loss in face,arm,leg
    boolean
    C3176213 (UMLS CUI [1])
    Symptoms Dysphasia/aphasia
    Item
    4. Symptoms: [B02] Dysphasia/aphasia (difficulty with language)
    boolean
    C0973461 (UMLS CUI [1])
    Symptoms Dysarthria/dysphagia
    Item
    4. Symptoms: [B03] Dysarthria/dysphagia (difficulty with speech and swallowing)
    boolean
    C0011168 (UMLS CUI [1,1])
    C0013362 (UMLS CUI [1,2])
    Symptoms Hemianopsia
    Item
    4. Symptoms: [B04] Hemianopsia
    boolean
    C0018979 (UMLS CUI [1])
    Symptoms Dizziness/vertigo
    Item
    4. Symptoms: [B05] Dizziness/vertigo
    boolean
    C0042571 (UMLS CUI [1])
    Symptoms Ataxia
    Item
    4. Symptoms: [B06] Ataxia
    boolean
    C0004134 (UMLS CUI [1])
    Symptoms Nystagmus
    Item
    4. Symptoms: [B07] Nystagmus
    boolean
    C0028738 (UMLS CUI [1])
    Symptoms Diplopia
    Item
    4. Symptoms: [B08] Diplopia
    boolean
    C0012569 (UMLS CUI [1])
    Symptoms Acute confusion/cognitive change
    Item
    4. Symptoms: [B09] Acute confusion/cognitive change
    boolean
    C0009676 (UMLS CUI [1])
    Symptoms Decreased consciousness
    Item
    4. Symptoms: [B10] Decreased consciousness
    boolean
    C0517960 (UMLS CUI [1])
    new focal neurologic deficit
    Item
    5. Did the subject have a new focal neurologic deficit thought to be of vascular origin, with signs or symptoms lasting >24 hours?
    boolean
    C0746857 (UMLS CUI [1])
    new brain infarct
    Item
    5. If neurologic symptoms <24 hours, was new brain lesion confirmed by diffusion-weighted MRI showing the presence of a new brain infarct?
    boolean
    C0333559 (UMLS CUI [1])
    Item
    6. Did neuro-imaging show an ischemic defect matching the clinical symptoms?
    text
    C0027853 (UMLS CUI [1])
    ischemic defect neuro-imaging
    Code List
    6. Did neuro-imaging show an ischemic defect matching the clinical symptoms?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not done (ND)
    Method of diagnosis Neurological exam
    Item
    7. Method of diagnosis: [B11] Neurological exam
    boolean
    C0027853 (UMLS CUI [1])
    Method of diagnosis Neuro-ophthalmologic exam
    Item
    7. Method of diagnosis: [B12] Neuro-ophthalmologic exam (retinal embolism, infarction)
    boolean
    C0027853 (UMLS CUI [1])
    Method of diagnosis CT scan
    Item
    7. Method of diagnosis: [B13] CT scan
    boolean
    C0040405 (UMLS CUI [1])
    Method of diagnosis MRI scan
    Item
    7. Method of diagnosis: [B14] MRI scan
    boolean
    C0917711 (UMLS CUI [1])
    Method of diagnosis Invasive angiography
    Item
    7. Method of diagnosis: [B15] Invasive angiography
    boolean
    C0085532 (UMLS CUI [1])
    Method of diagnosis Autopsy
    Item
    7. Method of diagnosis: [B16] Autopsy
    boolean
    C0004398 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [1,3])
    Method of diagnosis Other
    Item
    7. Method of diagnosis: [OT] Other
    boolean
    C2911685 (UMLS CUI [1])
    Item
    8. Was there a change in the modified Rankin Scale grade?
    text
    C2984908 (UMLS CUI [1])
    change in modified Rankin Scale grade
    Code List
    8. Was there a change in the modified Rankin Scale grade?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not available (NV)
    Most recent pre-event modified Rankin Scale grade
    Item
    8. Most recent pre-event modified Rankin Scale grade
    integer
    C2984908 (UMLS CUI [1])
    Date of most recent pre-event modified Rankin Scale grade
    Item
    8. Date of most recent pre-event modified Rankin Scale grade
    date
    C2984908 (UMLS CUI [1])
    Latest post-event modified Rankin Scale grade
    Item
    8. Latest post-event modified Rankin Scale grade
    integer
    C2984908 (UMLS CUI [1])
    Date of latest post-event modified Rankin Scale grade
    Item
    8. Date of latest post-event modified Rankin Scale grade
    date
    C2984908 (UMLS CUI [1])
    Item
    9. Type of stroke
    text
    C3897486 (UMLS CUI [1])
    Type of stroke
    Code List
    9. Type of stroke
    CL Item
    Ischemic (7)
    C0948008 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
    C0007785 (UMLS CUI-1)
    C2937358 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Hemorrhagic (37)
    C0333275 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Type uncertain (8)
    C0087130 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Not applicable (NP)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    narrative
    Item
    10. Provide narrative
    text
    C1135957 (UMLS CUI [1])
    Date documents sent to CEC Document Group
    Item
    11. Date documents sent to CEC Document Group
    date
    Item Group
    CEC Section
    Item
    8. Adjudication
    text
    C0680730 (UMLS CUI [1])
    Adjudication
    Code List
    8. Adjudication
    CL Item
    Does not meet criteria for stroke (NC)
    CL Item
    Non-fatal stroke (44)
    CL Item
    Fatal stroke (45)
    Item
    If non-fatal stroke, select one
    integer
    C0038454 (UMLS CUI [1])
    non-fatal stroke
    Code List
    If non-fatal stroke, select one
    CL Item
    Ischemic (7)
    C0948008 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
    (Comment:en)
    CL Item
    Hemorrhagic (37)
    (Comment:en)
    CL Item
    Type uncertain (8)
    (Comment:en)
    Non-fatal stroke type uncertain
    Item
    If type of non-fatal stroke uncertain, comment
    text
    Item
    If fatal stroke, select one
    integer
    C0038454 (UMLS CUI [1])
    fatal stroke
    Code List
    If fatal stroke, select one
    CL Item
    Ischemic (7)
    C0948008 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Cerebral infarction with blood felt to represent hemorrhagic conversion and not a primary hemorrhage (79)
    (Comment:en)
    CL Item
    Hemorrhagic (37)
    C0333275 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Type uncertain (8)
    (Comment:en)
    Fatal stroke, type uncertain
    Item
    If type of fatal stroke uncertain, comment
    text
    C0393963 (UMLS CUI [1])
    criteria for stroke not met, comment
    Item
    Does not meet criteria for stroke, comment
    text
    Item
    If criteria for stroke are not met, selet one
    text
    criteria for stroke not met
    Code List
    If criteria for stroke are not met, selet one
    CL Item
    TIA (6)
    CL Item
    Other (OT)
    criteria for stroke not met, other
    Item
    If other, please comment
    text
    Date of adjudication
    Item
    15. Date of adjudication
    date
    C3260278 (UMLS CUI [1])
    Item Group
    CEC STATUS
    Trigger number
    Item
    16. Trigger number
    text
    C1444748 (UMLS CUI [1])
    Item
    17. CEC Status
    integer
    C0449438 (UMLS CUI [1])
    CEC Status
    Code List
    17. CEC Status
    CL Item
    New (1)
    CL Item
    Coordinator Screen check (2)
    CL Item
    Hold (3)
    CL Item
    Ready for review (4)
    CL Item
    In Phase I review (5)
    CL Item
    Queried (InForm) (6)
    CL Item
    Additional documents required (7)
    CL Item
    In Phase II committee (8)
    CL Item
    Data change (9)
    CL Item
    Re-Review (10)
    CL Item
    Completed event (11)
    CL Item
    No event to adjudicate (12)
    CL Item
    QC Random sample (13)
    CL Item
    In Translation (14)
    Date of status change
    Item
    18. Date of status change
    date
    C0011008 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    Item
    19. Physician review #1: Physician
    integer
    Physician review 1
    Code List
    19. Physician review #1: Physician
    CL Item
    01 (1)
    CL Item
    02 (2)
    CL Item
    03 (3)
    CL Item
    04 (4)
    CL Item
    05 (5)
    CL Item
    06 (6)
    CL Item
    07 (7)
    CL Item
    08 (8)
    CL Item
    09 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    13 (13)
    CL Item
    14 (14)
    CL Item
    15 (15)
    CL Item
    16 (16)
    CL Item
    17 (17)
    CL Item
    18 (18)
    CL Item
    19 (19)
    CL Item
    20 (20)
    CL Item
    21 (21)
    CL Item
    22 (22)
    CL Item
    23 (23)
    CL Item
    24 (24)
    CL Item
    25 (25)
    CL Item
    26 (26)
    CL Item
    27 (27)
    CL Item
    28 (28)
    CL Item
    29 (29)
    CL Item
    30 (30)
    CL Item
    31 (31)
    CL Item
    32 (32)
    CL Item
    33 (33)
    CL Item
    34 (34)
    CL Item
    35 (35)
    CL Item
    36 (36)
    CL Item
    37 (37)
    CL Item
    38 (38)
    CL Item
    39 (39)
    CL Item
    40 (40)
    CL Item
    41 (41)
    CL Item
    42 (42)
    CL Item
    43 (43)
    CL Item
    44 (44)
    CL Item
    45 (45)
    CL Item
    46 (46)
    CL Item
    47 (47)
    CL Item
    48 (48)
    CL Item
    49 (49)
    CL Item
    50 (50)
    Physician review 1 Date sent to reviewer
    Item
    19. Physician review #1: Date sent to reviewer
    date
    C1515022 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Physician review 1 Date received from reviewer
    Item
    19. Physician review #1: Date received from reviewer
    date
    C0011008 (UMLS CUI [1])
    Item
    19. Physician review #2: Physician
    integer
    C3166277 (UMLS CUI [1])
    Physician review 1
    Code List
    19. Physician review #2: Physician
    CL Item
    01 (1)
    CL Item
    02 (2)
    CL Item
    03 (3)
    CL Item
    04 (4)
    CL Item
    05 (5)
    CL Item
    06 (6)
    CL Item
    07 (7)
    CL Item
    08 (8)
    CL Item
    09 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    13 (13)
    CL Item
    14 (14)
    CL Item
    15 (15)
    CL Item
    16 (16)
    CL Item
    17 (17)
    CL Item
    18 (18)
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    Physician review 2 Date sent to reviewer
    Item
    19. Physician review #2: Date sent to reviewer
    date
    C1515023 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Physician review 2 Date received from reviewer
    Item
    19. Physician review #2: Date received from reviewer
    date
    C3166277 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    CEC Coordinator comments
    Item
    21. CEC Coordinator comments
    text
    C1710220 (UMLS CUI [1,1])
    C0282411 (UMLS CUI [1,2])
    CV event number
    Item
    22. CV event number
    text
    C2826275 (UMLS CUI [1])
    Adverse event reference identifier
    Item
    23. Adverse event reference identifier
    text
    C1519255 (UMLS CUI [1,1])
    C2348585 (UMLS CUI [1,2])
    Adverse event term
    Item
    24. Adverse event term
    text
    C1516728 (UMLS CUI [1,1])
    C2826934 (UMLS CUI [1,2])
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